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Current Job Openings
Job Title: Validation Engineer (CQV)
Location: United States / Canada
Job Summary:
Support the commissioning, qualification, and validation of equipment, utilities, and facilities.
Write and review URS (User Requirements), FDS (Functional Specs), and validation quality strategy.
Execute IQ, OQ, PQ protocols and summarize results in final reports.
Perform risk assessments (e.g., FMEA), change control impact assessments.
Support FAT / SAT testing, collaborate with vendors during these phases.
Handle deviations, CAPAs, and investigation related to CQV activities.
Maintain compliance with regulatory requirements (cGMP, 21 CFR Part 11, etc.).
Qualifications:
Bachelor’s degree in Engineering, Life Sciences, or related discipline.
3–8 years of experience in pharmaceutical / biotech validation.
Knowledge of utility systems (e.g., WFI, clean steam), process control, automation, calibration.
Familiarity with quality systems and audits.
Job Title: Senior CQV Engineer / Validation Engineer (Consulting / Contractor)
Location: United States / Canada
Job Summary:
Serve as a validation subject matter expert for CQV activities (IQ, OQ, PQ) across client projects.
Lead or contribute to the creation, review, and execution of validation documentation (qualification protocols, reports, test plans).
Mentor junior validation engineers in best practices of CQV.
Engage in FAT (Factory Acceptance Testing), SAT, and other commissioning phases.
Collaborate with cross-functional teams: vendors, operations, quality, automation.
Plan and track CQV activities, resolve issues, close punch items, non-conformances, and deviations.
Participate in risk assessments, root cause analyses, and regulatory inspections / audits.
Qualifications:
Bachelor’s or Master’s degree in Engineering, Science, or a related field.
Minimum ~5 years of validation / commissioning experience in pharma / biotech.
Strong documentation skills and validation protocol expertise.
Excellent communication, problem solving, and project coordination capabilities.
Apply Now
Email your resume to jay@validationstar.com