Senior CQV Engineer - Senior Validation Engineer
A leading consultancy in the life sciences sector is hiring a Senior CQV Engineer to support validation efforts for process equipment, systems, and software. This role is ideal for professionals with a strong technical background in validation who want to work on high-impact healthcare projects in a collaborative, growth-oriented environment.
Key Responsibilities:
Develop and implement validation strategies, protocols, and documentation in accordance with regulatory standards
Conduct and document comprehensive impact and risk assessments across systems and processes
Lead and support execution of IQ/OQ/PQ protocols, including the testing of user interfaces, software functions, and alarms
Maintain precise documentation to support compliance and audit-readiness
Execute engineering studies to define and verify critical process parameters
Identify process improvement opportunities and recommend modifications based on test outcomes
Ensure project deliverables meet quality standards and timelines
Guide and mentor junior validation engineers within the team
Collaborate with internal and external stakeholders, including cross-functional client teams
What We're Looking For:
Bachelor's degree in engineering, life sciences, or related field (or equivalent experience)
4-6 years of hands-on CQV experience, particularly with process equipment in GMP environments
Solid understanding of validation lifecycle documents including URS, IQ, OQ, and PQ
Strong technical writing skills and attention to detail in validation recordkeeping
Experience leading testing efforts and performing software verifications
Proficiency with Microsoft Word, Excel, and PowerPoint
Ability to work independently and within team settings
Effective communicator with the ability to clearly explain technical requirements across organizational levels
Located in, or willing to work on-site in Kalamazoo, MI
Key Traits for Success:
Strong organizational and time management abilities
Collaborative, team-first attitude
Ability to think critically and troubleshoot complex issues
Confidence interacting with clients and delivering high-quality work under pressure
Willingness to take initiative and support business development when applicable
Why Join Us?
High-growth company culture with room for career development
Competitive salary and performance-based incentives
Full suite of health benefits including medical, dental, and vision coverage
Employer-paid disability and life insurance
401(k) plan with company match
Health Savings Account and FSA options
Paid holidays, PTO (with rollover), and sick time
Tuition reimbursement
Family-friendly policies, including parental leave and bereavement
Employee recognition programs and referral incentives
Regular team-building and social events
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