Lead CQV Engineer
Job in
City of Syracuse, New York, USA
Listed on 2025-11-27
Listing for:
consultpharmatek
Full Time
position Listed on 2025-11-27
Job specializations:
-
Engineering
Quality Engineering, Validation Engineer, Process Engineer, Biomedical Engineer
Job Description & How to Apply Below
Syracuse, United States | Posted on 07/16/2024
Contract Duration: 12+ Months, Potential to go longer
- 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
- 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
- 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
To View & Apply for jobs on this site that accept applications from your location or country, tap the button below to make a Search.
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
Search for further Jobs Here:
×