CSV Engineering Consultant (Onsite)

This is a 6 month onsite assignment with potential for extension based on performance.

Assignment Overview: Our client is a leading biopharmaceutical manufacturer who is currently in the process of ramping up their manufacturing plants on the East Coast. They currently need Computer System Validation Consultant to support the validation of enterprise and stand-alone computer systems. This consultant will be responsible for working closely with the client’s validation, manufacturing, and quality engineering teams to ensure that all commissioning, qualification, and validation activities are completed correctly. This consultant should be well-versed in computer system and software validation requirements. The ideal consultants will be responsible for both the development and execution of validation protocols.

This consultant will ensure current Good Manufacturing Practice (cGMP) regulations and the client’s PQS requirements are met for qualification/validation of manufacturing execution systems, process automation systems and related GMP computerized systems. He/She will apply knowledge of GMP computerized systems, qualification and validation principles, manufacturing processes, quality systems, engineering design fundamentals, health authority expectations and industry standards.

This project will give our consultants an opportunity to support an exciting expansion for one of the industry’s leading pharmaceutical manufacturers, ultimately ensuring that the company can manufacture and distribute lifesaving Covid therapies to patients around the world.

Technical Must Haves:
8 years of computer system validation experience (pharma/biopharma)
Experience writing and executing IQ/OQ/PQ
Experience validating enterprise computer systems
Experience validating stand-alone computer systems
Experience reviewing and revising SOPs
Direct experience with IT and MFG automation systems supporting GMP manufacturing
Direct experience implementing CSV activities to support GxP systems
Strong knowledge of FDA and cGMP regulations and documentation practices
Strong knowledge of GAMP 5
Must be able to be onsite for the duration of the project

Job Types: Full-time, Contract

Pay: $52.00 - $55.00 per hour

Benefits:

• Health insurance

Schedule:

• 8 hour shift

Ability to commute/relocate:

• Raleigh, NC 27604: Reliably commute or planning to relocate before starting work (Preferred)

Work Location: One location