Senior Process Engineer – Pharma Utilities & GMP Systems

TAI; Newark (DE); On-site; USD 125,000 - 175,000; Full time

Benefits offered by this job

Overtime eligibility

Profit sharing bonus

Health benefits

401(k) with employer match

PTO & paid holidays

Job summary

TAI is seeking a Senior Process (Utilities) Engineer/SME to lead design and coordination of critical process utility systems for pharma/biotech operations. You will develop technical specifications, studies, and oversee design packages while collaborating across disciplines.

This client-facing role requires eight+ years of experience in process design, PFDs/P&IDs, GMP construction, and familiarity with FDA/EMA standards.

Qualifications

• Bachelor’s degree in Mechanical or Chemical Engineering.
• Professional Engineer licensure is preferred.
• 8+ years of process design experience for diverse projects.
• 8+ years reviewing PFDs, P&IDs, specs for equipment and piping.
• 3+ years supporting Pharma/Biotech/Life Science projects.
• Subject Matter Expert in compressed air, clean rooms, GMP construction.
• Experience with FDA, EMA, and other regulatory standards.
• Knowledge of cGMP, ASME BPE, NFPA codes, and B31.3 piping.
• Knowledge of pumps, valves, control valves, meters, and controls.

Responsibilities

• Prepare Project Technical Requirements Specification for systems.
• Research industry standards and perform engineering studies.
• Develop engineering specifications and project cost estimates.
• Review design work and monitor scope changes with managers.
• Coordinate project documentation and CAD drawing preparation.
• Interpret codes and coordinate with officials and designers.
• Collaborate across engineering disciplines on project design.

Skills

Process design

PFDs & P&IDs

GMP/Pharma

Regulatory knowledge

Automation concepts

Education

Bachelors in Mechanical Engineering

Professional Engineer (PE) preferred

Tools

AutoCAD

Microsoft Office

Job description

TAI is seeking a Senior Process (Utilities) Engineer/SME to lead design and coordination of critical process utility systems for pharma/biotech operations. You will develop technical specifications, studies, and oversee design packages while collaborating across disciplines.

This client-facing role requires eight+ years of experience in process design, PFDs/P&IDs, GMP construction, and familiarity with FDA/EMA standards.