What are the responsibilities and job description for the CQV Engineer position at United Pharma Technologies Inc?
Job Title: CQV Engineer
Company: United Pharma Technologies
Location: Bristol, PA
Duration: Long Term
Industry: Pharmaceutical / Biotechnology – CDMO
Job Summary:
We are seeking an experienced CQV (Commissioning, Qualification, and Validation) Engineer to support equipment qualification activities for a Contract Development and Manufacturing Organization (CDMO) specializing in bioconjugate manufacturing. The ideal candidate will have strong pharmaceutical CQV experience and hands-on expertise in drafting and executing Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for process equipment.
Key Responsibilities:
- Draft, review, and execute IQ/OQ/PQ protocols for pharmaceutical manufacturing equipment.
- Perform qualification activities for mixers, reactors, tanks, process skids, and other bioconjugate manufacturing equipment.
- Ensure all qualification activities comply with cGMP requirements and applicable industry standards.
- Execute equipment testing, document results, and investigate discrepancies identified during qualification.
- Prepare and maintain qualification documentation, test records, and final reports.
- Collaborate with engineering, manufacturing, quality assurance, and validation teams to ensure successful qualification and project completion.
Required Qualifications:
- Minimum 5 years of experience in CQV engineering within the pharmaceutical or biotechnology industry.
- Proven experience drafting and executing IQ/OQ/PQ protocols for pharmaceutical process equipment.
- Hands-on experience qualifying mixers, reactors, tanks, and process skids.
- Strong understanding of cGMP requirements and equipment qualification practices.
- Ability to prepare accurate technical documentation and support qualification execution.
- CDMO experience is highly preferred, particularly in bioconjugate manufacturing environments.
Pay Scale
- Anticipated hourly pay range: $40/hr to $45/hr
Benefits
Employees hired into this position are eligible for the following benefits, subject to applicable plan terms and eligibility requirements:
Health Insurance: Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for paying the full cost of their insurance premiums.
Retirement Benefits: A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided.
Paid Time Off (PTO): No PTO is provided other than that required by applicable state and local law
Salary : $40 - $45