Lead CQV Engineer
About The Position
Role will drive the CQV strategy for the project, leading a team of engineers to successfully deliver deliverables Author, edit, and execute technical commissioning, qualification and validation documentation for standard equipment/systems/ software Adherence with project schedule for all assigned activities Maintaining clear, detailed records for qualification and validation Documenting impact and risk assessments as part of a team Making recommendations for design or process modification based on test results when executing test scripts General understanding of capital equipment implementation and process knowledge Understanding validation documentation from URS to Summary Reporting
Requirements
- Must be willing to work onsite in Syracuse, NY
- Minimum of 12 years of experience in CQV activities specific to a broad range of facility, utility, and process equipment including autoclaves, fillers, reactors, isolators, freezers, etc.
- Extensive experience authoring and executing IQ/OQ/PQ activities
- Ability to write sampling protocols and develop protocol templates
- Specific qualification experience with Autoclaves, TFF Skid, chrome skid (preferred)
- Experience qualifying Single User Reactors and Single Use Mixers (preferred)
- Experience developing and executing mixing studies
- Experience with clean room developing and/or executing EMPQ protocols
- Knowledge of Process Automation and equipment testing
- Experience using Delta V
- Bachelor's degree (minimum) in hard sciences, preferably Chemical Engineering
- Proficiency in using PC and Microsoft Office tools
- Outgoing personality with strong ability to communicate effectively with peers in clear, concise terms
- Ability to lead a team of engineers
- Strong problem -solving and critical thinking skills
- Excellent organizational and time management skills
- Strong attention to detail
- GMP and Good Documentation Practice knowledge
- Strong interpersonal skills and clear communication capabilities
- Experience with and tolerance for high levels of challenge and change
- Proven attention to detail and organization in project work
- Capable of working on assigned tasks without mentorship
Nice To Haves
- Specific qualification experience with Autoclaves, TFF Skid, chrome skid (preferred)
- Experience qualifying Single User Reactors and Single Use Mixers (preferred)
Responsibilities
- Drive the CQV strategy for the project
- Lead a team of engineers
- Author, edit, and execute technical commissioning, qualification and validation documentation
- Adhere to project schedule
- Maintain clear, detailed records for qualification and validation
- Document impact and risk assessments
- Make recommendations for design or process modification based on test results
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What This Job Offers
Career Level
Mid Level
