Commissioning & Qualification Engineer

Pinnaql • Guaynabo, PR

3d • Onsite

About The Position

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company 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 Technical Lead – Cleaning Characterization. Job Summary: We are seeking an experienced CQV Technical Lead – Cleaning Characterization to support a biologics drug substance technology transfer and manufacturing expansion project at a GMP facility in Juncos, Puerto Rico. The Technical Lead will provide technical leadership for cleaning characterization and verification activities associated with upstream and downstream manufacturing equipment and systems. The role will lead protocol development, execution readiness, field activities, data evaluation, discrepancy resolution, and final reporting while coordinating closely with Manufacturing, Engineering, Quality, QC Laboratories, and the client Verification team.

Requirements

• Bachelor's degree in Engineering, Science, Biotechnology, Microbiology, Chemistry, or related technical discipline.
• Significant CQV or validation experience in pharmaceutical or biotechnology manufacturing.
• Strong experience in cleaning validation, cleaning verification, or cleaning characterization.
• Demonstrated knowledge of: CIP systems and circuits, Bioprocess manufacturing equipment, Cleaning cycle parameters, Product-contact surface evaluations, TOC and microbial sampling, Dirty and clean hold-time concepts, GMP documentation
• Experience developing and executing cleaning protocols and reports.
• Strong technical writing and investigation skills.
• Ability to lead multidisciplinary teams in a GMP manufacturing environment.
• Ability to support non-standard schedules and 24/7 manufacturing execution periods when required.

Nice To Haves

• Previous cleaning verification experience at Amgen Manufacturing.
• Experience with biologics drug-substance manufacturing.
• Experience with upstream and downstream process equipment including: Bioreactors, Media and buffer tanks, Centrifuges, Chromatography skids, UF/DF systems, Transfer lines, Glassware washers
• Experience with OSIsoft PI / PI ProcessBook or PI Historian.
• Experience with LIMS, Kneat, Smartsheet, MAXIMO, LMS, or similar GMP systems.
• Experience supporting deviations, investigations, and CAPA.

Responsibilities

• Lead cleaning characterization and verification activities for upstream and downstream process systems.
• Develop, review, and support approval of technical documentation including: Cleaning Characterization Protocols, Acceptance criteria, Cleanability assessments, Sampling plans, Verification assessments, Interim summaries, Final reports
• Evaluate CIP circuits, cleaning sequences, operating parameters, equipment configurations, and product-contact surfaces.
• Review equipment drawings, isometrics, manufacturing procedures, batch records, PCS design documentation, and cleaning recipes.
• Calculate and verify product-contact surface areas.
• Perform field verification of equipment and product-contact surfaces.
• Develop sampling strategies including TOC and microbial surface sampling.
• Coordinate execution activities with Manufacturing, Engineering, QC, EHS, Quality, and other project stakeholders.
• Participate in commissioning or operational verification activities associated with new or modified CIP circuits.
• Analyze cleaning-cycle process data and PI Historian trends against established acceptance criteria.
• Ensure execution data are evaluated by the end of the applicable working shift.
• Lead technical triage of unexpected results, discrepancies, or execution issues.
• Support deviation investigations and associated CAPA activities when required.
• Support Cleaning Equipment Release for Use (RFU) and manufacturing changeover activities.
• Coordinate document generation and field execution schedules with other CQV personnel.
• Participate in manufacturing Work Center Team meetings during execution periods.
• Identify schedule or technical risks and recommend mitigation or recovery actions.
• Ensure reports are completed within required project timelines.

Benefits

• At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior