Job Description

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 Specialist– Cleaning Characterization

Job Summary:

We are seeking an experienced CQV Specialist - Cleaning Characterization to support the introduction of Repatha P5.0 into an existing biologics drug substance manufacturing facility in Juncos, Puerto Rico.

The CQV Specialist will support preparation, field execution, sampling, data analysis, discrepancy resolution, and reporting associated with cleaning characterization activities for upstream and downstream manufacturing systems.

Key Responsibilities

• Develop and execute cleaning characterization and verification protocols in accordance with approved procedures and GMP requirements.
• Review sequence of operations, CIP circuits, equipment configurations, cleaning recipes, manufacturing procedures, and applicable batch records.
• Support calculation and field verification of product-contact surface areas.
• Perform field walkdowns and visual inspections of process equipment.
• Assist with identification of critical and non-critical cleaning parameters.
• Prepare detailed sampling plans.
• Perform or coordinate TOC and microbial swab sampling.
• Maintain appropriate sample identification, custody, documentation, and traceability.
• Coordinate sample delivery and testing with QC laboratories.
• Support LIMS sample logging and results tracking.
• Review process data including temperature, flow, conductivity, time, and other relevant cleaning-cycle parameters.
• Generate and review PI Historian / PI ProcessBook trend charts.
• Evaluate execution results against protocol acceptance criteria.
• Immediately communicate unexpected or non-compliant results to project leadership.
• Support investigation and resolution of protocol discrepancies and deviations.
• Support Cleaning Equipment Release for Use and changeover activities.
• Prepare technical reports following completion of characterization activities.
• Perform peer review of calculations, technical data, and documentation generated by other team members.
• Work collaboratively with Manufacturing, Engineering, Quality, QC, EHS, Automation, and CQV personnel.
• Support execution during nights, weekends, and 24/7 manufacturing campaigns when required.

Required Qualifications

• Bachelor's degree in Engineering, Science, Biotechnology, Microbiology, Chemistry, or related field, or equivalent relevant industry experience.
• Previous CQV, validation, or verification experience in a GMP pharmaceutical or biotechnology environment.
• Experience with cleaning validation, cleaning verification, or cleaning characterization.
• Working knowledge of CIP processes and pharmaceutical manufacturing equipment.
• Experience with protocol generation, execution, and reporting.
• Strong GMP documentation and technical-writing skills.
• Ability to perform field-based validation activities in active manufacturing environments.

Preferred Qualifications

• Previous manufacturing or verification experience.
• Experience with biologics drug-substance operations.
• Experience with TOC and microbial surface sampling.
• Experience with OSI PI Historian / PI ProcessBook.
• Familiarity with LIMS, Kneat, Smartsheet, MAXIMO, LMS, or similar systems.
• Experience supporting cleaning Release for Use activities.

Schedule

The assignment is expected to support activities from Q4 2026 through Q2 2027, including critical manufacturing execution periods operating on a 7-day/24-hour schedule.

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.

Excited to build something meaningful together? We look forward to hearing from you.

Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.