Senior CQV Engineer On-Site Bioprocess Validation

Verista; Harvard (MA); On-site; USD 80,000 - 123,000; Full time

Benefits offered by this job

Competitive pay

Health insurance

401(k) plan

Paid time off

Tuition reimbursement

Life insurance

Job summary

Verista is seeking a Commissioning and Qualification Engineer to support installation, startup, commissioning and qualification of new single-use bioprocess equipment. You will collaborate with Process Engineering, Automation, CSV, Quality, equipment vendors and Operations to translate process requirements into qualification testing.

The role requires on-site work in Devens, MA, with a focus on IQ/OQ documentation, FAT/SAT activities and robust traceability across systems.

Qualifications

• Bachelor’s degree in Chemical, Mechanical, Biochemical Engineering or related field.
• 5+ years equipment commissioning/qualification or validation experience in biotech/pharma.
• Experience with bioprocess equipment (TFF skids, bioreactors, chromatography, single-use).

Responsibilities

• Support design reviews and equipment-system assessments.
• Review URSs, P&IDs, process-flow diagrams, equipment specs and vendor docs.
• Review control narratives, functional specs and I/O lists.

Skills

Commissioning

Qualification

Bioprocess equipment

FAT/SAT

Documentation

Vendor collaboration

IQ/OQ testing

Process validation

Education

Bachelor’s degree in Chemical/Mechanical/Biochemical Engineering

Tools

KrosFlo

ÄKTA

UNICORN

KlariFi

Lucullus

DeltaV

Job description

Verista is seeking a Commissioning and Qualification Engineer to support installation, startup, commissioning and qualification of new single-use bioprocess equipment. You will collaborate with Process Engineering, Automation, CSV, Quality, equipment vendors and Operations to translate process requirements into qualification testing.

The role requires on-site work in Devens, MA, with a focus on IQ/OQ documentation, FAT/SAT activities and robust traceability across systems.