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Engineer, IT Systems Compliance
Avid Bioservices
Tustin, USA
Full-time
Mid · 3+ years experience
Onsite
USD 82000-104400 yearly / year
Discovered 1 weeks ago
URSSOPsPart 11
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URSSOPsPart 11
Key Skills for This Role
URSSOPsPart 11
Full Job Posting
- Review and help author User Requirement Specification (URS) and/or Requirement Specification documents for manufacturing equipment/systems 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 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 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 reflects validated conditions.
- Assist department manager on other types of projects/managerial responsibilities as needed
- BA/BS in science (such as Biology, Microbiology, Biochemistry, Chemistry), Engineering (such as Electrical, Electronics, Computer Science) or other equivalent technology related field.
- Minimum of 3 years' work experience in biopharmaceutical/pharmaceutical manufacturing environment of which 1 year is directly involved in validations.
- You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.
- Your written and verbal skills are out of this world, and you communicate with clarity and confidence.
- You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything.
- You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.
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