Avid Bioservices Inc (CDMO)

[biopharm]

Job Posting Update: Avid : 1 added
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V 012214 Software Validation Engineer - New! ... job description posted at the bottom, time to verify, lock down and secure.... maybe require some RFID chips for all employees entering Bavi production/storage areas, hey... Bavituximab is pure gold and a life safer... literally!

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V 012214 Software Validation Engineer - New!


http://www.avidbio.com/about-us/careers.html

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3/25 filled: QA Document Coordinator - AVD 1010

3/21 filled: Manufacturing Technician (Support) provides support for Production Operations

6/14 filled: FAC 060613 Calibration/Maintenance Technician II

6/21 filled: MACC 2010 Manufacturing Associate - Cell Culture

7/16 added : QC 07162013 QC Analyst

7/18 added : M 07182013 Manufacturing Technician -

7/30 added : EMT 073013 Environmental Monitoring Technician

8/24 filled: QC 07162013 - QC Analyst Dept: Quality Control ... was removed sometime between 8/16 - 8/24

9/18 filled: M 07182013 - Manufacturing Technician

9/18 filled: EMT 073013 - Environmental Monitoring Technician

9/18 added: STM2012 Technician, Sr. Maintenance

10/14 added: EMT 073013 Sr. Environmental Monitoring Technician

10/20 filled:EMT 073013 Sr. Environmental Monitoring Technician

11/21 added: QCM 112113 Microbiologist

12/4 filled: STM2012 Technician, Sr. Maintenance Facilities & Maintenance

1/22 added: V 012214 Software Validation Engineer

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Job Code V 012214
Job Type Full-time
Job Status Interviewing
Location Tustin, CA
Department Validation
Company Information Avid Bioservices, Inc.
14282 Franklin Ave
Tustin, CA 92780
Website: http://www.avidbio.com

Job Description SUMMARY

This position shall provide technical validation support for computer systems, networks, and software that have been newly installed, upgraded, replaced and/or modified in the cGMP Manufacturing Facility as well as its related manufacturing support areas, which may include Facilities/Engineering, Quality Assurance, Supply Chain, and Quality Control.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Author User Requirement Specification (URS) and/or Requirement Specification documents for equipment/systems/software and processes.
• Generate and execute Installation, Operational and Performance/Process 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 reviewed and approved prior to the final summary report approval.
• 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 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 the validated conditions.
• Assist department manager on other types of projects/managerial responsibilities as needed.

QUALIFICATIONS

• Knowledge of validation principles, standard concepts, practices, procedures and requirements in GMP regulated environment with special focus on computerized systems and software.
• Additional experience may include but not limited to knowledge and understanding of manufacturing processes and equipment/process gap analysis.
• Understanding of Good Automated Manufacturing Practice (GAMP), ASTM E2500, 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, is organized and capable of working independently with minimal 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/OR EXPERIENCE

• Requires a BA/BS in a Computer Science or other related technology field
• Minimum of 3 years of computer system/software validation experience or an equivalent combination of education and experience.
• Minimum of 3 years in the pharmaceutical or biopharmaceutical industry with GMP experience.

COMPUTER SKILLS

• Knowledge of Microsoft Word, Excel, Outlook, Access and Power Point.
• Knowledge of Microsoft SharePoint.
• Knowledge of Asset Management Systems
• Familiarity with Microsoft Project, Visio and other tracking/database software.
• Familiarity with SCADA systems (hardware and software).
• Familiarity with Building Automation Systems (BAS).

http://www.avidbio.com/about-us/careers.html?task=view&id=86