6458 - Senior CQV Engineer / Senior Validation Engineer
$70,491–$109,900 year
On-siteBoston, Massachusetts, United States
Job Summary
Design validation plans, conduct risk assessments, and execute engineering studies for critical process parameters. Author and edit technical commissioning documentation, run test scripts, and document results for compliance audits. Complete user interface testing, software verification, and alarm testing on automated systems while making recommendations for design modifications based on test findings. Maintain clear records of qualification and validation activities and adhere to project schedules. Must work onsite in the Boston metropolitan area with 10-50% travel requirements. Salary range $70,491–$109,900 USD. Requires 4-6 years of experience in pharmaceutical manufacturing GMP environments and a Bachelor's degree.
Required Qualifications
- Must be able/willing to work onsite in the Boston metropolitan area
- Must be willing to meet potential future travel requirements (10-50%)
- Bachelor's Degree or equivalent required
- 4 - 6 years of demonstrated role relevant experience
- Demonstrated experience in leading CQV activities specific to pharmaceutical manufacturing requirements
- Experience in GMP regulated environment
- Capable of working on assigned tasks without mentorship
Desired Qualifications
- Ability to mentor and guide less experienced team members
- Ability to communicate effectively with clients
- Proven ability to identify areas of business expansion and report to management team for follow-up
- Obvious business maturity and interpersonal skills to be able to effectively communicate and collaborate
- Experience and capability of effectively communicating requirements (written and orally) with rationale to different levels of the client's organization
- Outgoing personality with strong ability to communicate effectively with peers in clear, concise terms
- Ability to work as part of a team
- Strong problem-solving and critical thinking skills
- Excellent organizational and time management skills
- Strong attention to detail
- GMP and Good Documentation Practice
- Intermediate skills with WORD (authoring/editing large technical documents with styles, tables, TOCs, track changes)
- Basic skills with EXCEL and PowerPoint
- 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
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