Project Engineer III
Validation & Engineering Group, Inc
Job Description
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:
- 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.
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