Cqv Validation Jobs in Puerto Rico (NOW HIRING)

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:

• Project Engineer - Process

Description:

• Provides owner-side project-engineering support to the Process Lead during the Buffer Prep / Buffer Hold (BPBH) brownfield expansion within an active 24/7 GMP facility.
• Acts as owner's representative for the process equipment installation package - coordinating and overseeing the General Contractor's execution, owning field-level permit-to-work, walkdowns, safety, and coordination, and supporting the Process Lead in reviewing the A/E's process design.
• Design authority and responsibility rest with the Process Lead and the A/E; this role actively supports design review and owns owner-side execution oversight.
• The incumbent supports the Lead, owns the owner-side coordination of the process package, and develops process-engineering expertise through the project.

Responsibilities:

• Serves as owner's representative for the process equipment package (tanks, skids, heat exchangers, transfer panels/manifolds, CIP/SIP) during brownfield construction; provides day-to-day oversight of the General Contractor (GC) and its subcontractors for this scope, monitoring progress, quality, and compliance against the approved design.
• Owns permit-to-work (PTW) coordination and issuance for process construction activities within the active 24/7 GMP facility; enforces construction segregation from live manufacturing and coordinates tie-ins/shutdown windows with site operations.
• Conducts and participates in field walkdowns, inspections, and punch-list development for the process equipment and process-mechanical scope; verifies installed work matches design and site standards before turnover.
• Supports construction safety participates in contractor safety evaluations, supports the site safety plan for process activities, and ensures GC adherence to EHS requirements on an active manufacturing site.
• Acts as liaison and coordination point between the GC, the A/E (Fluor), site operations, and the Process Lead; ensures construction activities do not negatively impact ongoing production.
• Supports the Process Lead in reviewing A/E design deliverables (drawings, specifications, P&IDs, process control narratives); reviews GC submittals and RFIs for alignment with standards. (Design review and support role - design authority and responsibility rest with the Process Lead and the A/E.)
• Maintains as-built documentation and field records for the process equipment and process-mechanical package; tracks open items, field issues, and schedule for the scope and escalates to the Process Lead.
• Supports commissioning, turnover, and startup for the process equipment and process-mechanical package; assists the Lead and CQV team with field troubleshooting and system handover to operations.
• Supports the Process Lead during vendor process-equipment installation (buffer tanks, process skids, heat exchangers (HEX), transfer panels, CIP tie-ins); coordinates GC mechanical/process installation and witnesses field activities.
• Supports FAT/SAT and process commissioning activities; assists with field data collection and troubleshooting of newly installed process systems.

Qualifications:

• Bachelor's degree in Chemical, Biomedical, or Mechanical Engineering.
• 3-7 years of experience in pharmaceutical/biotech or industrial capital projects, ideally in an owner's-representative or GC/EPC field-engineering capacity.
• Experience with brownfield construction in an operating facility: permit-to-work systems, field walkdowns, construction safety, and contractor coordination.
• Working familiarity with biologics process systems - buffer prep/hold tanks, process skids, heat exchangers (HEX), transfer panels/manifolds, CIP/SIP tie-ins, and hygienic process piping - sufficient to support the Lead and coordinate the GC (design-level mastery is not required at this level).
• GMP awareness and the ability to coordinate work safely within an active 24/7 manufacturing environment.
• Construction management exposure or coursework; ability to read and interpret construction drawings and specifications.
• Prior commissioning / CQV field-support experience.
• Must be fully bilingual (English / Spanish) with excellent oral skills.
• Technical Writing skills and investigations processes.
• Available to work extended hours, possibility of weekends and holidays.

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.