Avid Bioservices Inc (CDMO)

[biopharm]

Job Posting Update : Peregrine/Avid : close to 30...

more new jobs on the way... up to 32 now and all the brand new jobs posted recently, some just posted yesterday June 22... are included below the full list below:

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http://peregrineinc.applicantpro.com/jobs/


Current Job Listings

Below is a list of the current openings with our company. Click on the job title to learn more about the opening.
Biotech Environmental Monitoring Technician - Microbiological Quality Control

Avid - QC MicroTustin, CA, USA03-Jul-2015Full Time

Business Systems Analyst

PPHM - Information TechnologyTustin, CA, USA31-Aug-2015Full Time

Clinical Data Specialist

PPHM - Clinical OPSTustin, CA, USA30-Jul-2015Full Time

Clinical Project Manager

PPHM - Clinical OPSTustin, CA, USA30-Jul-2015Full Time

Clinical Trial Manager/Sr. Manager

PPHM - PPHM - Clinical ResearchTustin, CA, USA31-Jul-2015Full Time

Director, Quality Control - Biologics

Avid - Quality ControlTustin, CA, USA25-Jul-2015Full Time

Director, Regulatory Affairs

PPHM - Reg AffairsTustin, CA, USA31-Jul-2015Full Time

Director/Sr. Director, Quality Assurance

PPHM - QualityTustin, CA, USA31-Jul-2015Full Time

Dynamics AX Systems Administrator

PPHM - Information TechnologyTustin, CA, USA31-Aug-2015Full Time

ERP Dynamics AX Manager

PPHM - Information TechnologyCA, USA31-Aug-2015Full Time

In-Vitro Lab Technician

PPHM - OperationsTustin, CA, USA18-Sep-2015Full Time

Manufacturing Associate/Sr. Associate - Downstream (4 day/10 hour daytime shifts)

Avid - ManufacturingTustin, CA, USA30-Jul-2015Full Time

Manufacturing Associate/Sr. Associate - Upstream (Days - 4 day/10 hour daytime shifts)

Avid - ManufacturingTustin, CA, USA30-Jul-2015Full Time

Manufacturing Supervisor - Biotech Downstream

Avid - ManufacturingTustin, CA, USA15-Jul-2015Full Time

Manufacturing Supervisor - Biotech Upstream

Avid - ManufacturingTustin, CA, USA15-Jul-2015Full Time

Manufacturing Technician - Cleanroom Escort (Biotech)

Avid - ManufacturingTustin, CA, USA07-Jul-2015Full Time

Manufacturing Technician/Associate - Formulations

Avid - ManufacturingTustin, CA, USA07-Jul-2015Full Time

QC In-Process Analyst/Sr. Analyst

Avid - Quality ControlTustin, CA, USA31-Jul-2015Full Time

Quality Control Supervisor

Avid - Quality ControlTustin, CA, USA31-Jul-2015Full Time

Quality Engineer - Avid

Avid - Quality ControlTustin, CA, USA31-Aug-2015Full Time

Research Associate - Downstream

PPHM - Process SciencesTustin, CA, USA31-Jul-2015Full Time

Research Associate - Molecular Cell Biology

PPHM - Process SciencesTustin, CA, USA31-Aug-2015Full Time

Scientific Writer (Process)

PPHM - Process SciencesTustin, CA, USA30-Jul-2015Full Time

Sr. Maintenance Technician

Avid - FacilitiesTustin, CA, USA30-Jul-2015Full Time

Sr. QA Specialist/QA Specialist - Compliance

Avid - Quality AssuranceTustin, CA, USA31-Jul-2015Full Time

Sr. QA Specialist/QA Specialist - MQA

Avid - Quality AssuranceTustin, CA, USA31-Jul-2015Full Time

Sr. QC ELISA Chemist

PPHM - Process SciencesTustin, CA, USA31-Aug-2015Full Time

Sr. Quality Control Analyst

Avid - Quality ControlTustin, CA, USA02-Jul-2015Full Time

Sr. Research Scientist, Protein Characterization

PPHM - Process SciencesTustin, CA, USA31-Jul-2015Full Time

Sr. Specialist, Clinical Supplies

PPHM - Clinical OPSCA, USA31-Aug-2015Full Time

Sr. Specialist, QA - Audit

Avid - Quality AssuranceTustin, CA, USA15-Jul-2015Full Time

Validation Engineer

Avid - ValidationsCA, USA31-Aug-2015Full Time


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Business Systems Analyst

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22-Jun-2015 to 31-Aug-2015 (PST)
Information Technology
Tustin, CA, USA
Hourly
Full Time



Peregrine Pharmaceuticals, on the list of Deloitte & Touche's 500 fastest growing North American technology companies, invites you to bring us your excellent hands-on clinical supplies expertise in the pharmaceutical industry to become part of our successful team. Peregrine has launched a Phase III lung cancer clinical trial for our lead drug therapy Bavituximab which has been given a fast-track designation by the FDA.

SUMMARY

Conduct analysis on complex system requests and translate business requirements into system functional and non-functional requirements. Identify and resolve gaps to ensure technical requirements are complete, accurate and actionable.


ESSENTIAL DUTIES AND RESPONSIBILITIES

• Builds strong working relationships with the business requestors, business analysts, developers and testers.
• Identifies and escalates as necessary, gaps in requirement alignment with strategies as well as across projects and teams.
• Document system requirements.
• Owns, manages and resolves questions, issues and risks related to requirements.
• Ensures the developers and testers have the requirements they need to be successful and that they align to the business requirements
• Acts as the Subject Matter Expert on systems and answers customers software questions.
• Create, maintain, and execute on delivery of business requirements, functional specifications, and test cases/steps.
• Evaluate evolving business requirements and recommends appropriate systems alternatives and/or enhancements to current systems
• Use best practices and knowledge of internal or external business issues to improve services and solve long-term problems.
• Develop solutions to complex problems, requiring the regular use of ingenuity and creativity, within the larger context of the business needs and objectives.
• Support and coordinate System Integration Testing, User Acceptance Testing, and associated activities such as test plan, test cases and test execution as related to enhancements to a production environment
• Triage production issues, provide a work around as applicable and work with appropriate teams or vendors to finding solutions
• Creates/updates knowledge articles for service desk to help with issue resolution for external users.

QUALIFICATIONS

• Bachelor's Degree
• 5+ years as a Business/Systems Analyst
• Specialized education in tools and techniques of business process analysis, re-engineering, or project management is a plus.
• Proven ability to understand complex system integration
• Strong analytical and problem-solving skills
• Strong interpersonal, communication, leadership, presentation and negotiating skills
• Excellent written and verbal communication skills
• Skilled at tackling unusual and complex challenges, can guide and advise others
• Willingness and ability to share knowledge
• Integrity and high ethical standards
• Attention to detail

RELOCATION AVAILABLE

Please note this position is based in Orange County, CA and is an onsite role. Competitive relocation assistance within the continental USA will be provided for well-qualified individuals.

EQUAL OPPORTUNITY/AFFIRMATIVE ACTION EMPLOYER

Peregrine Pharmaceuticals and Avid Bioservices do not discriminate against any employee or applicant for employment because of race, color, religion, sex, national origin, age, marital status, genetic information, disability or because he or she is a protected veteran.

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Dynamics AX Systems Administrator

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22-Jun-2015 to 31-Aug-2015 (PST)
Information Technology
Tustin, CA, USA
Hourly
Full Time

Peregrine Pharmaceuticals, on the list of Deloitte & Touche's 500 fastest growing North American technology companies, invites you to bring us your excellent hands-on clinical supplies expertise in the pharmaceutical industry to become part of our successful team. Peregrine has launched a Phase III lung cancer clinical trial for our lead drug therapy Bavituximab which has been given a fast-track designation by the FDA.

SUMMARY

Responsible for the development, support, upgrades and enhancements of Dynamics AX and other Microsoft Dynamics integration. Partner with vendors and users to optimize systems in order to increase user productivity and company efficiency. Maintaining corporate IT infrastructure by monitoring, troubleshooting and resolving system related matters.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Maintain production and non-production environments of Microsoft Dynamics AX
• Anticipate, migrate, identify, troubleshoot and resolve hardware and software problems on servers, workstations, printers and mobile devices. Escalate when necessary.
• Recommend, schedule and perform software and hardware improvements, upgrades, patches, reconfigurations and/or purchases
• Conduct research on emerging products, services, protocols and standards that will be of value to the company
• Participate in negotiations with vendors, outsources and contractors to secure software products and services
• Develop and maintain an understanding of application dependencies, workflows, integrations and processes surrounding applications
• Create and manage end user accounts, permissions and access rights
• Perform routine backups and audits on IT systems
• Assist users with IT systems

QUALIFICATIONS

• AA or Bachelor's degree in computer science, engineering or related field
• 5+ years experience configuring and supporting Microsoft Dynamics AX 2012 R2
• Proven ability to train users and host dept. training on systems and applications
• Working knowledge of computer hardware and network systems
• Hands-on software and hardware troubleshooting experience

RELOCATION AVAILABLE

Please note this position is based in Orange County, CA and is an onsite role. Competitive relocation assistance within the continental USA will be provided for well-qualified individuals.

EQUAL OPPORTUNITY/AFFIRMATIVE ACTION EMPLOYER

Peregrine Pharmaceuticals and Avid Bioservices do not discriminate against any employee or applicant for employment because of race, color, religion, sex, national origin, age, marital status, genetic information, disability or because he or she is a protected veteran.

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ERP Dynamics AX Manager

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22-Jun-2015 to 31-Aug-2015 (PST)
Information Technology
CA, USA
Salary
Full Time

Peregrine Pharmaceuticals, on the list of Deloitte & Touche's 500 fastest growing North American technology companies, invites you to bring us your excellent hands-on clinical supplies expertise in the pharmaceutical industry to become part of our successful team. Peregrine has launched a Phase III lung cancer clinical trial for our lead drug therapy Bavituximab which has been given a fast-track designation by the FDA.

SUMMARY

Oversee and implement Dynamics AX technical solutions used across the Enterprise regarding industry specific business applications.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Responsible for application design, feature optimization, availability, scalability, user experience, visualization and data integrity related to key aspects of an enterprise
• Manage entire project lifecycle, resources to meet company success
• Collaborate with business units to gather in depth understanding of the business, business operations and business needs to define the configuration, customization and management of Microsoft Dynamics AX solutions
• Perform gap analysis between Dynamics AX functionality and business unit's requirements
• Responsible for leading effective change management within Dynamics AX
• Lead the team to define solutions roadmap for the implementation of upgrades and/or hotfixes
• Develop functional specifications including use cases, business scenarios and functional requirements for the platform
• Designing, building, testing and deploying the functional components required for successful Microsoft Dynamics AX solutions, including reports

QUALIFICATIONS

• Bachelor's degree in Computer Science or related field
• Proven extensive knowledge and abilities performing in Dynamics AX 2009 and 2012 systems (core, external components and architecture) as well as other Microsoft solution offerings
• 5+ years hands-on work experience with Dynamics AX
• Desired not required: Certifications within Dynamics AX
• Desired not required: Demonstrates proven extensive knowledge with managing the life cycle of Microsoft Dynamics AX implementations which includes working directly with business units, gathering requirements to deliver effective solutions, actively engaging in the implementations of solutions and assisting business units with training as necessary.

RELOCATION AVAILABLE

Please note this position is based in Orange County, CA and is an onsite role. Competitive relocation assistance within the continental USA will be provided for well-qualified individuals.

EQUAL OPPORTUNITY/AFFIRMATIVE ACTION EMPLOYER

Peregrine Pharmaceuticals and Avid Bioservices do not discriminate against any employee or applicant for employment because of race, color, religion, sex, national origin, age, marital status, genetic information, disability or because he or she is a protected veteran.

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In-Vitro Lab Technician

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19-Jun-2015 to 18-Sep-2015 (PST)
Operations
Tustin, CA, USA
Full Time

In-Vitro Lab Technician



Peregrine Pharmaceuticals, on the list of Deloitte & Touche's 500 fastest growing North American technology companies, invites you to bring us your excellent hands-on clinical data expertise and pharmaceutical industry experience to become part of our successful team. Peregrine has launched a Phase III lung cancer clinical trial for our lead drug therapy Bavituximab which has been given a fast-track designation by the FDA.



SUMMARY



Performing the immunological assays, in-vitro cell manipulations and analyzing the data. Assist in the development and maintenance of laboratory quality control (QC) methods and records. Interpret and document results.



ESSENTIAL DUTIES and RESPONSIBILITIES



Administer assays to measure the efficacy of therapeutics in vitro studies

Perform and analyze flow cytometry assays, including intracellular cytokine staining (ICS)

Purify T-lymphocyte populations from spleen

Perform cell culture

Provide laboratory support to ongoing research efforts within the Division.

Document weekly research progress using Microsoft Office based applications.

Assist in the development and maintenance of laboratory quality control (QC) methods and records. Interpret and report on experimental results

Develop and trouble-shoot new assays as needed

Maintain a high level of accuracy for all work

Maintain records for experiments and quality control for the laboratory

Prepare and maintain reagents, stocks, and cultures necessary to perform the work

Operate and carry out basic maintenance and QC of laboratory equipment

Perform other duties as assigned



QUALIFICATIONS



High school Diploma required; Bachelor's degree preferred but not required

6 months -3 years exp. in bio-assay, Cytokine, FACS Analysis and in-vitro cell manipulations

MUST be available to work over-time, variable work schedules, weekends & holiday IF needed

Understanding of GLP (Good Lab Practices) and must be able to practice it.

Understanding of GMP (Good Manufacturing Practices) is a plus.

Need understanding of sterile technique and laboratory etiquette (i.e. proper PPE, proper laboratory attire, etc.).

Proven ability to document results and keep organized records.

Require basic computer skills and working knowledge of MS Office etc.



NOTE – Please send resume/cv in an MS Word attachment

EQUAL OPPORTUNITY/AFFIRMATIVE ACTION EMPLOYER

Peregrine Pharmaceuticals and Avid Bioservices do not discriminate against any employee or applicant for employment because of race, color, religion, sex, national origin, age, marital status, genetic information, disability or because he or she is a protected veteran.

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Quality Engineer - Avid

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10-Jun-2015 to 31-Aug-2015 (PST)
Quality Control
Tustin, CA, USA
Salary
Full Time

Avid Bioservices is an established Contract Manufacturing Organization (CMO) based in Orange County, CA. We are a subsidiary of Peregrine Pharmaceuticals which is on the list of Deloitte & Touche's 500 fastest growing North American technology companies. Avid invites you to bring us your excellent quality engineering skills and proven abilities in the life sciences industry. We encourage you to apply to become part of our successful team if you meet the following criteria:

SUMMARY

The Quality Engineer shall provide technical validation support for processes, equipment, networks, software that has been newly installed, upgraded, replaced and modified in Quality Control. This role is the primary interface with Quality Control for Validations and Facilities on QC equipment

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Plan and procure new QC equipment needed to support Myford and Franklin labs
• Plan and coordinate potential movement of QC equipment from Franklin to Myford
• Generate and review relevant documents for new equipment
• Schedule and manage routine PM on QC equipment
• Assess equipment needs for QC and manage equipment purchasing process
• Write and manage Engineering Change Request (ECR) documents
• Author User Requirement Specification (URS) and/or Requirement Specification documents for quality control equipment/systems and processes
• Generate and execute Installation, Operational and Performance/Process qualification (IQ, OQ, PQ) protocols and final reports that comply with corporate and regulatory requirements
• Coordinate and oversee validation protocol execution or validation activities
• Evaluate and analyze qualification data collected during projects while verifying acceptability of the data and compliance with the approved protocol
• Ensure any deviations to protocols and/or deviations to acceptance criteria are adequately addressed, documented and reviewed
• Improve validation and equipment processes
• Assist department manager in developing realistic time and resource requirements for validation activities in support of company expectations
• Provide input and assist in change control assessment and Part 11 assessment for validated systems
• Review Standard Operating Procedures (SOPs) and ensure the operational parameters described in the SOP for the equipment reflect validated conditions
• Assist department manager on other types of projects/managerial responsibilities as needed
• Schedule and manage routine instrument PM processes

QUALIFICATIONS

• Requires a BA/BS in Science (such as Biology, Microbiology, Biochemistry, Chemistry) or other technologically related field
• A minimum of five years' work experience in a biopharmaceutical/pharmaceutical manufacturing environment of which 3 years were directly involved in validations is essential
• Must have knowledge of validation principles, standard concepts, practices, procedures and requirements in a GMP regulated environment
• Additional experience may include but is not limited to knowledge and understanding of manufacturing processes, Computerized System Validation, Software Validation and equipment/process gap analysis
• An understanding of Good Automated Manufacturing Practice (GAMP), SDLC, Risk Assessment and 21 CFR Part 11 Electronic Records and Electronic Signatures is required
• Normally receives general instructions on routine validation work and on new assignments/projects
• Relies on experience and judgment to plan and accomplish goals
• Must be able to multi-task, be organized and capable of working independently with minimal or no supervision

RELOCATION AVAILABLE

Please note this position is based in Orange County, CA and is a full time onsite role. Competitive relocation assistance within the continental USA will be provided for well-qualified individuals.

EQUAL OPPORTUNITY/AFFIRMATIVE ACTION EMPLOYER

Peregrine Pharmaceuticals and Avid Bioservices do not discriminate against any employee or applicant for employment because of race, color, religion, sex, national origin, age, marital status, genetic information, disability or because he or she is a protected veteran.

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Research Associate - Molecular Cell Biology

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10-Jun-2015 to 31-Aug-2015 (PST)
Process Sciences
Tustin, CA, USA
Hourly
Full Time

Peregrine Pharmaceuticals, on the list of Deloitte & Touche's 500 fastest growing North American technology companies, invites you to bring us your excellent hands-on research expertise and proven abilities in the pharmaceutical industry. Peregrine has launched a Phase III lung cancer clinical trial for our lead drug therapy Bavituximab, which has been given a fast-track designation by the FDA.

SUMMARY

The Research Associate provides laboratory support for Process Sciences and performs a range of activities. This position may be assigned various tasks within the department to complete.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Assist in mammalian cell culture:
o including media formulation/preparation
o freezing, thawing, and testing of cell banks
o subcloning and screening
o cell counting, expanding and harvesting
o manage large numbers of cultures at a time, ranging from multi-well plates to T-flasks, spinner flasks and bioreactors
o assist in setting up bioreactors and in protein production
o transient and stable transfection
o high through put cultures for media/feed optimization
o generation/cell line stability studies
• Assist in expression vector design and construction for generating stable cell lines:
o DNA extraction, both plasmid and gDNA
o Design PCR and sequencing primers
o Perform PCR
o Restriction digestion analysis and agarose gel electrophoresis
o Bacterial transformation, plating and culture
o DNA sequence analysis
o DNA manipulation/subcloning
• Protein concentration by A280
• SDS-PAGE and IEF gels
• IgG titer assay by ELISA and/or HPLC
• ELISA binding assays
• Host Cell Protein ELISA
• Assist in formulation and/or product stability studies
• Buffer preparation
• Assisting in compilation of data for reports
• Data entry/analysis
• Data presentation in Process Science Group Meeting

QUALIFICATIONS

Requires a BS degree in the life sciences. A degree in molecular biology or cell biology is highly desirable. A minimum of 1 - 2 years of related work experience in the pharmaceutical industry is essential.

EQUAL OPPORTUNITY/AFFIRMATIVE ACTION EMPLOYER

Peregrine Pharmaceuticals strongly supports and values the uniqueness of all individuals and promotes a work environment where diversity is embraced.

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Sr. QC ELISA Chemist

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22-Jun-2015 to 31-Aug-2015 (PST)
Process Sciences
Tustin, CA, USA
Full Time

Peregrine Pharmaceuticals, on the list of Deloitte & Touche's 500 fastest growing North American technology companies, invites you to bring us your excellent hands-on clinical supplies expertise in the pharmaceutical industry to become part of our successful team. Peregrine has launched a Phase III lung cancer clinical trial for our lead drug therapy Bavituximab which has been given a fast-track designation by the FDA.

SUMMARY

Perform testing and sampling to support manufacturing, validation, process development, raw materials and stability studies in a GMP environment. Supports and leads continuous improvement initiatives.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Perform and review routine wet chemistry/raw material assays and ELISA, electrophoresis (SDS-PAGE/IEF) and HPLC.
• Perform aseptic sampling
• May train/supervise the experimental work of more junior analysts and may be a member of interdepartmental/tech transfer teams.
• Review, revise and write test methods, standard operating procedures and may perform trending analysis.
• May be designated as study Lead for validation projects, investigations and method development projects.
• Conduct Potency/ELISA assay methodologies
• Knowledgeable of company cGMPs as well as industry regulations that apply to job functions.

QUALIFICATIONS

• A BS degree in Biochemistry, Chemistry, Biology or a related field is required.
• 5+ years of biotech industry experience working in a QC or Research lab.
• Solid Potency/ELISA experience is required.
• Proven exp. with analytical testing and equipment utilizing analytical biochemistry methods, writing reports/procedures/specifications, GMPs and regulatory audits.. Working knowledge of: protein characterization, electrophoresis, chromatography, aseptic techniques, and assay validation/qualification.

COMPUTER SKILLS

• Proficiency in MS Office, technical writing and data analysis using Excel.
• Ability to operate analytical equipment using MS Windows based software systems is required.

RELOCATION AVAILABLE

Please note this position is based in Orange County, CA and is an onsite role. Competitive relocation assistance within the continental USA will be provided for well-qualified individuals.

EQUAL OPPORTUNITY/AFFIRMATIVE ACTION EMPLOYER

Peregrine Pharmaceuticals and Avid Bioservices do not discriminate against any employee or applicant for employment because of race, color, religion, sex, national origin, age, marital status, genetic information, disability or because he or she is a protected veteran.

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Sr. Specialist, Clinical Supplies

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16-Jun-2015 to 31-Aug-2015 (PST)
Clinical OPS
CA, USA
Salary
Full Time

Peregrine Pharmaceuticals, on the list of Deloitte & Touche's 500 fastest growing North American technology companies, invites you to bring us your excellent hands-on clinical supplies expertise in the pharmaceutical industry to become part of our successful team. Peregrine has launched a Phase III lung cancer clinical trial for our lead drug therapy Bavituximab which has been given a fast-track designation by the FDA.

SUMMARY

The Sr. Specialist, Clinical Supplies will be responsible for the design, set up and execution of timely, efficient and effective supply chains supporting multiple clinical trials. Responsibilities include various aspects of ensuring clinical supply including forecasting, manufacturing, inventory and distribution plans along with effective planning of clinical supplies to ensure timely study starts and ongoing re-supplies.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Manage the planning, manufacturing and logistics of clinical material supply to support various clinical programs including multiple ISTs and late stage clinical trials
• Budget and manage costs associated with clinical supply management and distribution for clinical trials
• Coordinate and oversee clinical material packaging and labeling activities at third party vendors
• Develop clinical label and packaging requirements and specifications
• Develop distribution and return drug plans
• Lead comparator sourcing and planning activities
• Coordinate with Regulatory and Clinical Operations in ensuring clinical trial supply requirements and regulations are met

QUALIFICATIONS

We require a Bachelor's degree in a scientific discipline with a minimum of 5 years of biotechnology or pharmaceutical industry experience working in a GMP environment supporting clinical cold chain drug supply activities. Additional required qualifications are as follows:

• Must have demonstrated experience leading clinical supplies planning and logistics activities for early and late stage global clinical trials
• Need experience developing and managing budgets and associated tracking of work versus invoices
• Experience in biologics based clinical supplies is essential
• Experience in label and packaging design development is highly desirable
• Experience working with IVR, IWRS, etc. is required

OTHER REQUIREMENTS

Occasional overnight travel by land and/or air may be required to attend meetings, out of state site visits, conferences, etc.

RELOCATION AVAILABLE

Please note this position is based in Orange County, CA and is a full time onsite role. Competitive relocation assistance within the continental USA will be provided for well-qualified individuals.

EQUAL OPPORTUNITY/AFFIRMATIVE ACTION EMPLOYER

Peregrine Pharmaceuticals and Avid Bioservices do not discriminate against any employee or applicant for employment because of race, color, religion, sex, national origin, age, marital status, genetic information, disability or because he or she is a protected veteran.

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Validation Engineer

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22-Jun-2015 to 31-Aug-2015 (PST)
Validations
CA, USA
Salary
Full Time

Avid Bioservices is an established Contract Manufacturing Organization (CMO) based in Orange County, CA. We are a subsidiary of Peregrine Pharmaceuticals which is on the list of Deloitte & Touche's 500 fastest growing North American technology companies. Avid invites you to bring us your excellent validation expertise and proven abilities in the biotech industry.

SUMMARY

The Validation Engineer shall provide technical validation support for processes, equipment and systems that have been newly installed, upgraded, replaced and/or modified in the Manufacturing Facility as well as its related manufacturing support areas which may include Facilities/Engineering, Supply Chain and Quality Control.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Author User Requirement Specification (URS) and/or Requirement Specification documents for manufacturing equipment/systems and processes.
• Generate and execute Installation, Operational and Performance qualification (IQ, OQ, PQ) protocols, engineering studies and final reports that comply with corporate and regulatory requirements.
• Coordinate and oversee validation protocol execution or validation activities with cross-functional departments.
• Evaluate and analyze qualification data collected during projects while verifying acceptability of the data and compliance with the approved protocol.
• Ensure any deviations to protocols and/or deviations to acceptance criteria are adequately addressed, documented and reviewed by the Validation Committee.
• Provide input and assist on the development of validation policies and procedures.
• Effectively interact and provide validation guidance to other departments.
• Assist department manager in developing realistic time and resource requirements for validation activities in support of company expectation.
• Provide input and assist in change control and risk assessments for validated systems.
• Review Standard Operating Procedures (SOPs) and ensure the operational parameters described in the SOP reflect validated conditions.
• Assist department manager on projects/managerial responsibilities as needed.

QUALIFICATIONS

• Knowledge of validation principles, standard concepts, practices, procedures and requirements in GMP regulated environment.
• Must have experience working with equipment used for the manufacture of monoclonal antibodies.
• Additional experience may include, but not limited to: knowledge and understanding of manufacturing processes, Computerized System Validation, Software Validation and equipment/process gap analysis.
• Understanding of Good Automated Manufacturing Practice (GAMP), SDLC, Risk Assessment and 21 CFR Part 11 Electronic Records and Electronic Signatures.
• Knowledgeable with Programmable Logic Controllers (hardware and software).
• Normally receives general instructions on routine validation work and on new assignments/projects.
• Relies on experience and judgment to plan and accomplish goals.
• Multi-tasks, organized and capable of working independently with minimal or no supervision.
• Looks for opportunities to assist others and works well in a team environment.
• Communicates effectively with customers, peers, and management.
• Demonstrates respect and appreciation for a diversity of perspectives.
• Maintains professionalism in presence of conflict.
• Takes accountability for actions, drives results, and learns from mistakes.
• Practical experience with quality risk management and risk-based validation.
• Demonstrates excellent organizational and time management skills.

EDUCATION AND EXPERIENCE

• Requires a BA/BS in Life Sciences, i.e. Biology, Microbiology, Biochemistry or Chemistry.
• Minimum of 5 years work experience in a biopharmaceutical/pharmaceutical manufacturing environment of which 3 years are directly involved in validations.

COMPUTER SKILLS

• Knowledge of Microsoft Word, Excel, Outlook and Power Point.
• Familiarity with Microsoft Project, Visio and other tracking/database software.

RELOCATION AVAILABLE

Please note this position is based in Orange County, CA and is an onsite role. Competitive relocation assistance within the continental USA will be provided for well-qualified individuals.

EQUAL OPPORTUNITY/AFFIRMATIVE ACTION EMPLOYER

Peregrine Pharmaceuticals and Avid Bioservices do not discriminate against any employee or applicant for employment because of race, color, religion, sex, national origin, age, marital status, genetic information, disability or because he or she is a protected veteran.

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