CQV Engineer

United Pharma Technologies Inc; Bristol Township (Bucks County); On-site; USD 55,000 - 62,000; Full time

Benefits offered by this job

Health Insurance

401(k) Retirement Plan

Paid Time Off

Job summary

United Pharma Technologies Inc. is seeking an experienced CQV Engineer to support equipment qualification activities at a pharmaceutical CDMO specializing in bioconjugate manufacturing.

This role focuses on IQ, OQ, and PQ protocols for process equipment. You will draft, execute, and review qualification tests for mixers, reactors, tanks, and process skids, ensuring cGMP compliance and alignment with industry standards.

Qualifications

• Minimum 5+ years of CQV engineering experience in pharma/biotech.
• Proven ability to draft and execute IQ/OQ/PQ for process equipment.
• CDMO experience in bioconjugate manufacturing preferred.

Responsibilities

• Draft, review, and execute IQ/OQ/PQ protocols for equipment.
• Qualify mixers, reactors, tanks, and process skids.
• Ensure cGMP compliance and industry standards.
• Prepare qualification documentation and final reports.

Skills

CQV engineering

IQ/OQ/PQ drafting

cGMP knowledge

Documentation skills

Job description

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

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