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– Sterilization / SIP

Job Summary:

We are seeking an experienced CQV Specialist – Sterilization / SIP to support sterilization qualification activities associated with the introduction of a biologics drug substance process into an existing GMP manufacturing facility in Juncos, Puerto Rico.

The individual will support development and execution of sterilization qualification protocols, including SIP and applicable autoclave activities, thermometric studies, biological indicator studies, process-data evaluation, conditional release, discrepancy resolution, and final reporting.

Key Responsibilities

• Develop and execute sterilization qualification protocols.
• Support SIP qualification activities for upstream and downstream manufacturing systems.
• Support qualification of new or impacted autoclave cycles and loads where applicable.
• Review system design, sequence of operations, operational parameters, manufacturing procedures, equipment documentation, and associated recipes.
• Identify critical and non-critical sterilization parameters.
• Support thermometric qualification studies.
• Prepare and handle biological indicators as required by approved protocols.
• Coordinate instrumentation, thermocouples, equipment availability, and execution logistics.
• Coordinate activities with Manufacturing, Engineering, QC, EHS, Quality, and CQV personnel.
• Evaluate sterilization-cycle process data including:
• Temperature profiles
• Exposure times
• Lethality
• Flow and process conditions
• Other protocol-defined parameters
• Generate and evaluate PI Historian / PI ProcessBook trend charts.
• Analyze cycle data against protocol acceptance criteria by the end of the applicable working shift.
• Support sterilization Conditional Release activities.
• Immediately identify and communicate unexpected results or protocol discrepancies.
• Support technical investigations, deviations, and corrective actions.
• Prepare and route sterilization qualification reports for review and approval.
• Participate in peer review of calculations and technical data.
• Support night, weekend, or continuous manufacturing schedules when required.

Required Qualifications

• Bachelor's degree in Engineering, Science, Microbiology, Biotechnology, or related technical field.
• CQV or validation experience within a GMP pharmaceutical or biotechnology facility.
• Hands-on sterilization qualification experience.
• Experience with SIP and/or autoclave qualification.
• Knowledge of thermometric qualification methodologies.
• Experience using biological indicators during sterilization studies.
• Understanding of sterilization-cycle parameters and lethality concepts.
• Experience generating and executing protocols and preparing final reports.
• Strong GMP documentation and technical-writing capabilities.

Preferred Qualifications

• Experience supporting biologics drug-substance manufacturing.
• Previous Amgen CQV or verification experience.
• Experience with OSIsoft PI / PI ProcessBook or PI Historian.
• Experience supporting deviation investigations.
• Experience with Kneat, LIMS, MAXIMO, Smartsheet, LMS, or equivalent systems.

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.