CQV Engineer

Research And Development Engineer – Thermal

Job Description

This position is responsible for the successful implementation and coordination of equipment and facilities validation programs in compliance with cGMPs, FDA requirements, and company policy. Development and execution of validation protocols is the primary responsibility. The role ensures that each validation study is accurate, complete, and acceptable to FDA standards.

• Participate in the commissioning, qualification, and startup of various pharmaceutical cGMP process and packaging equipment, utilities, and facilities.
• Coordinate, develop, and prepare installation, operation, and performance qualification protocols for production equipment and related facilities (including HVAC, compressed air, and purified water systems).
• Coordinate and perform the execution of validation studies; prepare validation reports, including data analysis, conclusions, and recommendations.
• Lead the development of key qualification deliverables such as DQ, FAT, SAT, IQ, OQ, and PQ during the project lifecycle.
• Execute field qualification test cases and protocols.
• Lead qualification processes throughout the project lifecycle to ensure timely completion and that all quality and engineering specifications are met.
• Demonstrate knowledge of relevant regulatory requirements and industry best practices for process equipment, clean utilities, automation systems, laboratory equipment, building & facilities.
• Perform other related assignments and duties as required.

• Bachelor’s degree in engineering, a scientific discipline, or another relevant field.
• 7+ years of experience in commissioning, qualification, and validation of various systems within the pharmaceutical/biotech industry.
• Knowledge of cGMPs and FDA guidelines and regulations acquired through education, experience, and training.
• Experience with commissioning and qualification of equipment & facilities.
• Experience with cleaning validation, thermal validation, mixing studies, process validation, or computer systems validation (asset but not required).
• Experience with commissioning and qualification of process control systems (PCS, SCADA, historians) and building automation systems (asset).
• Experience with preparing and executing URS, DQ, RTM, risk assessments, CPPs, VPPs, FATs, SATs, IOQs.
• Ability to handle multiple projects in a fast‑paced environment.
• Strong multitasking skills.
• Effective written and oral communication skills.
• High proficiency in preparing documents with MS Word and editing Access databases.

Location:

Raleigh-Durham-Chapel Hill Area

Salary: $80,000.00 – $

Employment type:

Contract

Seniority level:
Mid‑Senior level

Job function:
Pharmaceutical Manufacturing (Industry)