Senior Pharma Process Engineer — cGMP Design Lead

BSI Engineering LLC; Mason (OH); Hybrid; USD 130,000 - 190,000; Full time

Benefits offered by this job

PTO and Paid Holidays

Paid overtime

401(k) with matching

Health, Dental, and Vision

Paid Charitable Effort Time

Tuition Reimbursement

Flexible Telecommuting Policy

Job summary

BSI Engineering is seeking a Senior Process Engineer in Mason, OH to lead design and execution of pharmaceutical process systems from concept through startup, ensuring cGMP compliance and patient safety. You will work on API and drug product projects with clean utilities and equipment sizing, collaborating across disciplines.

The ideal candidate has 10+ years of experience in regulated manufacturing, strong knowledge of 21 CFR Parts 210/211, and a track record in delivering FAT/SAT, IQ/OQ/PQ,

Qualifications

• Bachelor of Science in Chemical, Biochemical, or Mechanical Engineering.
• 10+ years of process engineering experience in pharmaceutical, API, or cGMP manufacturing.
• Experience designing regulated cGMP facilities across concept to construction support.
• Knowledge of 21 CFR Parts 210/211 and ISPE Baseline Guides is a plus.

Responsibilities

• Lead site visits, surveys, and cleanroom assessments in cGMP facilities.
• Develop URS, BOD, and Process Design Basis reports.
• Create BFDs, PFDs, P&IDs, and M&EBs for process and utilities.
• Coordinate with multi-discipline teams including piping, HVAC, automation.
• Develop FATs/SATs and support IQ/OQ/PQ qualification activities.

Skills

cGMP knowledge

Regulatory compliance

Mentoring

Client interface

Education

Bachelor of Science in Chemical/Biochemical/Mechanical Engineering

Tools

PIPE-FLO

Aspen Plus

ProSim

CHEMCAD

Job description

BSI Engineering is seeking a Senior Process Engineer in Mason, OH to lead design and execution of pharmaceutical process systems from concept through startup, ensuring cGMP compliance and patient safety. You will work on API and drug product projects with clean utilities and equipment sizing, collaborating across disciplines.

The ideal candidate has 10+ years of experience in regulated manufacturing, strong knowledge of 21 CFR Parts 210/211, and a track record in delivering FAT/SAT, IQ/OQ/PQ,