Lead Validation Engineer - Downstream Biotech CQV

Validation & Engineering Group; Juncos (PR); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading services supplier in biotech in Juncos, Puerto Rico, is seeking a qualified individual to develop and execute commissioning and qualification protocols for pharmaceutical and biotech projects. The ideal candidate will have 3–7 years of CQV experience in a GMP-regulated environment and strong knowledge of downstream unit operations. This role involves coordinating with vendors to ensure compliance and executing essential field inspections to guarantee equipment operates according to design specifications. Competitive candidates will possess excellent communication skills and familiarity with validation systems.

Qualifications

• 3–7 years of CQV experience in a GMP-regulated biotech or pharmaceutical environment.
• Proficient in writing and executing validation protocols within electronic systems.
• Familiarity with single-use technologies in downstream processing is preferred.

Responsibilities

• Develop and execute commissioning and qualification protocols for equipment.
• Coordinate FAT/SAT execution with vendors and engineering teams.
• Perform field inspections during commissioning.

Skills

CQV experience

Communication and documentation skills

Understanding of downstream unit operations

Understanding of FDA, EMA, and ICH guidelines

Education

Bachelor’s degree in engineering or related life sciences

Tools

Valgenesis

Kneat

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.

Job Description

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:

• Tangential Flow Filtration (TFF) systems.
• 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

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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