CQV Engineer: Biotech Plant Startup & Commissioning

Intellectt INC; Holly Springs (NC); On-site; USD 59,000 - 65,000; Full time

Job summary

Intellectt INC in Holly Springs, NC seeks a CQV Engineer to support commissioning and qualification of new pharmaceutical/biotech manufacturing units, focusing on hands-on field execution, C&Q, equipment startup, and verification of upstream/downstream process equipment.

The role emphasizes field work, review of turnover packages, system completion walkdowns, and documentation of CQV activities, including process automation verification and associated utilities.

Qualifications

• Hands-on commissioning and qualification experience in pharma/biotech.
• Experience with upstream and/or downstream process equipment.
• P&ID field verification and turnover package reviews.
• Familiarity with process automation and utilities.

Responsibilities

• Perform field verification of P&IDs, equipment datasheets, vendor drawings, isometrics, utility connections, and system boundaries against as-built conditions.
• Conduct system completion walkdowns and review turnover packages.
• Verify construction readiness, punch-list closure, weld documentation, calibration records, and redlines.
• Execute commissioning and qualification activities for upstream and downstream process equipment.
• Support equipment/system startup and identify and resolve startup issues.
• Execute C&Q activities for bioreactors, media prep systems, incubators, pumps, and centrifuges.
• Support downstream equipment including chromatography skids, UF/DF systems, and viral filtration systems.
• Verify process automation and associated utility systems.
• Complete required CQV documentation and ensure accurate field documentation.

Skills

C QV Experience

Field Verification

P&ID Familiarity

Equipment Startup

Process Automation

Bioprocess Equipment

Job description

Intellectt INC in Holly Springs, NC seeks a CQV Engineer to support commissioning and qualification of new pharmaceutical/biotech manufacturing units, focusing on hands-on field execution, C&Q, equipment startup, and verification of upstream/downstream process equipment.

The role emphasizes field work, review of turnover packages, system completion walkdowns, and documentation of CQV activities, including process automation verification and associated utilities.