Commissioning & Qualification Lead � Upstream & Downstream Process Equipment LL05-250822

Veg Group; Juncos (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

A leading engineering firm in Puerto Rico is seeking a CQV Lead for upstream and downstream biotech process equipment. The ideal candidate will have a Bachelor’s or Master’s degree with 7-10 years of CQV experience in GMP biopharmaceutical manufacturing. Responsibilities include leading CQV efforts, managing engineers, and ensuring compliance with regulatory standards. This role demands strong communication and problem-solving skills, along with technical expertise in biotech systems.

Qualifications

• Minimum 7–10 years of CQV experience in GMP biopharmaceutical manufacturing.
• Demonstrated experience leading CQV teams in facility startups, tech transfers, or capital projects.
• Strong technical knowledge of both upstream (cell culture) and downstream (purification) processes.

Responsibilities

• Lead CQV efforts for upstream and downstream equipment, ensuring alignment with overall project schedule.
• Manage CQV engineers and contractors; assign responsibilities and oversee protocol development.
• Develop CQV strategy, work plans, and schedules in alignment with URS and compliance requirements.

Skills

Leadership & Project Management

Technical knowledge of biotech systems

Excellent communication skills

Problem-solving skills

Education

Bachelor’s or Master’s degree in Engineering, Biotechnology, or related field

Tools

Kneat

Valgenesis

DeltaV

Rockwell

Siemens PCS

Job description

Career Opportunities with Validation & Engineering Group

A great place to work.

Current job opportunities are posted here as they become available.

Commissioning & Qualification Lead – Upstream & Downstream Process Equipment LL05-250822

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 Lead – Upstream & Downstream Biotech Process Equipment

The CQV Lead will be responsible for overseeing all commissioning, qualification, and validation activities related to upstream and downstream process equipment in a biotech GMP manufacturing facility. This includes strategic planning, resource coordination, protocol development, execution oversight, and stakeholder engagement across the CQV lifecycle. The role requires a strong technical background in cell culture and purification systems, as well as leadership experience in cross-functional environments supporting project delivery, regulatory compliance, and schedule milestones.

Key Responsibilities:

Leadership & Project Management

Lead CQV efforts for upstream and downstream equipment, ensuring alignment with overall project schedule and quality standards.

Manage CQV engineers and contractors; assign responsibilities and oversee protocol development and execution activities.

Represent CQV function in cross-functional meetings with QA, Manufacturing, Automation, Process Engineering, and Project Controls.

Develop CQV strategy, work plans, and schedules in alignment with URS, risk assessments, and cGMP expectations.

Support the resolution of deviations, non-conformances, and issues identified during commissioning and qualification.

Documentation & Execution Oversight

Oversee the preparation and approval of commissioning plans, IQ/OQ/PQ protocols, risk assessments, and summary reports.

Ensure traceability from URS to qualification deliverables (RTM).

Approve system walkdowns, punchlist resolutions, and impact assessments.

Lead or support FAT/SAT coordination and vendor engagements.

Compliance & Quality Assurance

Ensure CQV activities are conducted in accordance with FDA, EMA, ICH Q8–Q10, ISPE Baseline Guide Vol. 5, and ASTM E2500.

Collaborate with QA to ensure timely approvals of protocols and reports.

Ensure all validation deliverables support readiness for regulatory inspections and PPQ readiness.

Equipment in Scope:

Upstream Systems:

Bioreactors (single-use and stainless steel)

Media preparation systems and skids

Cell culture support equipment (incubators, mixing tanks)

Control systems for pH, DO, temperature, agitation

Seed train and expansion systems

Downstream Systems:

Tangential flow filtration (TFF) skids

Centrifuges and depth filtration units

Bulk hold tanks and transfer skids

CIP/SIP systems interfacing with both upstream and downstream trains

Qualifications:

Bachelor’s or Master’s degree in Engineering, Biotechnology, or related Life Sciences field.

Minimum 7–10 years of CQV experience in GMP biopharmaceutical manufacturing.

Demonstrated experience leading CQV teams in facility startups, tech transfers, or capital projects.

Strong technical knowledge of both upstream (cell culture) and downstream (purification) processes.

In-depth understanding of validation lifecycle and GMP documentation.

Excellent communication, coordination, and problem-solving skills.

Preferred Experience:

Use of electronic validation platforms (e.g., Kneat, Valgenesis).

Familiarity with DeltaV, Rockwell, or Siemens PCS automation.

Previous experience on large-scale biotech capital projects (greenfield/brownfield).

Experience interfacing with Quality Assurance and regulatory auditors.