Job Description

Job Description

Job Description

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

• CQV Specialist for Biotech Downstream Process Equipment

The CQV Specialist will support the commissioning and qualification of downstream process equipment for a GMP-compliant biotechnology manufacturing facility. The role involves hands-on execution of IQ/OQ/PQ protocols, system walkdowns, and validation documentation for equipment such as chromatography skids, TFF systems, ultrafiltration units, centrifuges, and bioburden reduction filtration systems. The ideal candidate will have prior experience with biotech processes, familiarity with regulatory standards (FDA/EU Annex 15), and the ability to work cross-functionally with engineering, QA, and operations teams.

Key Responsibilities:

• Develop, review, and execute commissioning and qualification protocols (IQ/OQ/PQ) for downstream processing equipment.
• Coordinate FAT/SAT execution and documentation with vendors and engineering teams.
• Perform field inspections, loop checks, and functional verifications during commissioning.
• Ensure equipment is installed and operates per design specifications, user requirements, and cGMP standards.
• Support resolution of deviations and discrepancies identified during commissioning and qualification.
• Author and/or review commissioning plans, traceability matrices, risk assessments, and validation summary reports.
• Interface with validation, manufacturing, automation, and QA to ensure alignment and timely execution of CQV activities.
• Participate in change control evaluations and equipment impact assessments.

Downstream Equipment in Scope:

• Chromatography Skids.
• Tangential Flow Filtration (TFF) systems.
• Depth filtration units.
• Centrifuges and continuous flow centrifuges.
• Virus filtration and inactivation systems.
• Bulk product hold tanks and transfer skids.
• Clean-in-place (CIP) and Steam-in-place (SIP) systems.

Qualifications:

• Bachelor’s degree in engineering, biotechnology, or related life sciences discipline.
• 3–7 years of CQV experience in a GMP-regulated biotech or pharmaceutical environment.
• Strong understanding of downstream unit operations and associated automation.
• Proficient in writing and executing validation protocols and working within electronic validation systems (e.g., Valgenesis, Kneat).
• Familiarity with FDA, EMA, and ICH guidelines.
• Excellent communication and documentation skills.

Preferred Skills:

• Experience with single-use technologies (SUT) in downstream processing.
• Knowledge of DeltaV, Rockwell, or Siemens PLC-based automation systems.
• Experience working on greenfield or facility expansion projects.

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