GMP Process Engineer: Commissioning & CQV for Biotech

Trinity Consultants - Advent Engineering; Boston (MA); On-site; USD 80,000 - 110,000; Full time

Job summary

Trinity Consultants - Advent Engineering is looking for experienced Process Engineers based in Boston, MA to support capital projects within GMP-regulated environments. This role involves reviewing design packages, providing engineering oversight, and ensuring compliance during installation and commissioning activities.

The ideal candidate should have strong commissioning and validation experience, with at least 4 years in pharmaceutical or biotechnology manufacturing, and possess a Bachelor's degree in Engineering.

Qualifications

• 4+ years of experience in pharmaceutical or biotechnology manufacturing.
• Strong experience in commissioning, qualification, validation, and engineering documentation.
• Ability to read engineering drawings, P&IDs, and vendor documentation.

Responsibilities

• Review engineering design packages and vendor submittals.
• Provide engineering oversight during installation and commissioning.
• Support deviation investigations and continuous improvement initiatives.

Skills

GMP-regulated pharmaceutical or biotechnology manufacturing

Commissioning

Qualification

Validation

Technical writing

Cross-functional collaboration

Education

Bachelor’s degree in Engineering (Chemical, Mechanical, Electrical or related)

Tools

CMMS

BMS

EMS

SCADA systems

Job description

Trinity Consultants - Advent Engineering is looking for experienced Process Engineers based in Boston, MA to support capital projects within GMP-regulated environments. This role involves reviewing design packages, providing engineering oversight, and ensuring compliance during installation and commissioning activities.

The ideal candidate should have strong commissioning and validation experience, with at least 4 years in pharmaceutical or biotechnology manufacturing, and possess a Bachelor's degree in Engineering.