Senior CQV Engineer - Bioprocess Equipment Validation

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

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Health Savings Account (HSA)

401(k) matching

Paid Time Off

Tuition Reimbursement

Life Insurance

Disability Insurance

Commuter Benefits

Job summary

Verista, a leader in life sciences services, seeks a Commissioning and Qualification Engineer for on-site deployment in Devens, MA. You will support installation, startup, commissioning and qualification of single-use bioprocess equipment, collaborating with Process Engineering, Automation, CSV, Quality, and operations to translate process requirements into robust testing.

The role requires 5+ years in equipment commissioning/validation in biotech/pharma, experience with TFF skids, bioreactors,

Qualifications

• Bachelor’s degree in Chemical Engineering or related discipline.
• 5+ years in equipment commissioning, qualification, process engineering or validation in biotech/pharma manufacturing.
• Experience with bioprocess equipment (TFF skids, bioreactors, chromatography, single-use systems).
• Experience executing FAT, SAT, commissioning, IQ or OQ activities.
• Ability to read P&IDs, FS, control narratives and I/O docs.
• Strong field execution, troubleshooting and technical writing.

Responsibilities

• Support design reviews and equipment-system assessments.
• Review URS, P&IDs, process-flows, equipment specs and vendor docs.
• Review control narratives, FS and I/O lists.
• Support FAT/SAT, commissioning, IQ/OQ activities.
• Verify installation against drawings and specs.
• Develop and execute commissioning, IQ and OQ documentation.
• Coordinate punch-list resolution and system turnover.
• Provide CSV support during testing.

Skills

Commissioning

Qualification

Process Engineering

Validation

Biotech/Pharma

Education

Bachelor’s degree in Chemical Engineering

Tools

KrosFlo

ÄKTA

UNICORN

Single-use bioreactors

DeltaV

KlariFi

Lucullus

Job description

Verista, a leader in life sciences services, seeks a Commissioning and Qualification Engineer for on-site deployment in Devens, MA. You will support installation, startup, commissioning and qualification of single-use bioprocess equipment, collaborating with Process Engineering, Automation, CSV, Quality, and operations to translate process requirements into robust testing.

The role requires 5+ years in equipment commissioning/validation in biotech/pharma, experience with TFF skids, bioreactors,