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LL05-250822 - CQV Lead – Upstream & Downstream Biotech Process Equipment

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<strong><em>Validation & Engineering Group, Inc. </em></strong>(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.<br><br>We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:<br><br>CQV Lead – Upstream & Downstream Biotech Process Equipment<br><br>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.<br><br><strong>Key Responsibilities<br><br></strong><strong>Leadership & Project Management<br><br></strong><ul><li>Lead CQV efforts for upstream and downstream equipment, ensuring alignment with overall project schedule and quality standards. </li><li>Manage CQV engineers and contractors; assign responsibilities and oversee protocol development and execution activities. </li><li>Represent CQV function in cross-functional meetings with QA, Manufacturing, Automation, Process Engineering, and Project Controls. </li><li>Develop CQV strategy, work plans, and schedules in alignment with URS, risk assessments, and cGMP expectations. </li><li>Support the resolution of deviations, non-conformances, and issues identified during commissioning and qualification. <br><br></li></ul><strong>Documentation & Execution Oversight<br><br></strong><ul><li>Oversee the preparation and approval of commissioning plans, IQ/OQ/PQ protocols, risk assessments, and summary reports. </li><li>Ensure traceability from URS to qualification deliverables (RTM). </li><li>Approve system walkdowns, punchlist resolutions, and impact assessments. </li><li>Lead or support FAT/SAT coordination and vendor engagements. <br><br></li></ul><strong>Compliance & Quality Assurance<br><br></strong><ul><li>Ensure CQV activities are conducted in accordance with FDA, EMA, ICH Q8–Q10, ISPE Baseline Guide Vol. 5, and ASTM E2500. </li><li>Collaborate with QA to ensure timely approvals of protocols and reports. </li><li>Ensure all validation deliverables support readiness for regulatory inspections and PPQ readiness. <br><br></li></ul><strong>Equipment In Scope<br><br></strong><strong>Upstream Systems:<br><br></strong><ul><li>Bioreactors (single-use and stainless steel) </li><li>Media preparation systems and skids </li><li>Cell culture support equipment (incubators, mixing tanks) </li><li>Control systems for pH, DO, temperature, agitation </li><li>Seed train and expansion systems <br><br></li></ul><strong>Downstream Systems<br><br></strong><ul><li>Chromatography systems (Protein A, IEX, etc.) </li><li>Tangential flow filtration (TFF) skids </li><li>Virus filtration/inactivation systems </li><li>Centrifuges and depth filtration units </li><li>Bulk hold tanks and transfer skids </li><li>CIP/SIP systems interfacing with both upstream and downstream trains <br><br></li></ul><strong>Qualifications<br><br></strong><ul><li>Bachelor’s or Master’s degree in Engineering, Biotechnology, or related Life Sciences field. </li><li>Minimum 7–10 years of CQV experience in GMP biopharmaceutical manufacturing. </li><li>Demonstrated experience leading CQV teams in facility startups, tech transfers, or capital projects. </li><li>Strong technical knowledge of both upstream (cell culture) and downstream (purification) processes. </li><li>In-depth understanding of validation lifecycle and GMP documentation. </li><li>Excellent communication, coordination, and problem-solving skills. <br><br></li></ul><strong>Preferred Experience<br><br></strong><ul><li>Use of electronic validation platforms (e.g., Kneat, Valgenesis). </li><li>Familiarity with DeltaV, Rockwell, or Siemens PCS automation. </li><li>Previous experience on large-scale biotech capital projects (greenfield/brownfield). </li><li>Experience interfacing with Quality Assurance and regulatory auditors.</li></ul>

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