6468 - Senior CQV Engineer / Senior Validation Engineer

About the Role

We are seeking a Commissioning and Qualification Engineer to support the installation, startup, commissioning, and qualification of new single-use bioprocess equipment. The engineer will collaborate closely with Process Engineering, Automation, CSV, Quality, equipment vendors, and Operations. This role requires strong equipment and process knowledge, with the ability to translate process requirements into meaningful commissioning and qualification testing.

Responsibilities

• Support design reviews and equipment-system assessments.
• Review URSs, P&IDs, process-flow diagrams, equipment specifications, and vendor documentation.
• Review control narratives, functional specifications, and I/O lists.
• Support equipment FAT and SAT activities.
• Perform equipment walkdowns and verify installation against approved drawings and specifications.
• Support commissioning, startup, and turnover activities.
• Develop and execute commissioning, IQ, and OQ documentation.
• Verify instrumentation, calibration status, utilities, and equipment components.
• Support loop checks and I/O verification.
• Challenge alarms, interlocks, permissives, and equipment safety functions.
• Test equipment operating sequences, recipes, phases, and process transitions.
• Support pump, valve, flow, pressure, temperature, weight, and mixing-function testing.
• Support PID-loop verification and process stabilization.
• Coordinate punch-list resolution and system turnover.
• Document discrepancies and support investigation and resolution.
• Support engineering runs, water runs, buffer runs, and initial process execution.
• Provide process and equipment SME support during CSV testing.
• Support SOPs, operating instructions, maintenance procedures, and training.

Requirements

• Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Biochemical Engineering, or a related discipline.
• Approximately five or more years of equipment commissioning, qualification, process engineering, or validation experience in biotechnology or pharmaceutical manufacturing.
• Experience with bioprocess equipment such as TFF skids, bioreactors, chromatography systems, or single-use processing equipment.
• Experience executing FAT, SAT, commissioning, IQ, or OQ activities.
• Ability to read P&IDs, functional specifications, control narratives, and I/O documentation.
• Experience testing alarms, interlocks, permissives, and automated operating sequences.
• Strong field-execution, troubleshooting, and technical-writing skills.
• Ability to work directly with vendors, Operations, Engineering, and Quality.
• Experience with KrosFlo, ÄKTA chromatography, and UNICORN preferred.
• Experience with single-use bioreactors.
• Exposure to KlariFi, Lucullus, or DeltaV.
• Experience with PID-controlled process systems.
• Experience supporting equipment startup within a new or renovated GMP facility.
• This role requires the ability to be on-site, full-time in Devens, MA.

Company Culture & Values

• We empower and support our colleagues.
• We commit to client success at every turn.
• We have the courage to do the right thing.
• We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.
• We constantly acquire new skills and learn from our experiences to enhance our collective expertise.

Pay

National (US) salary range: $80,465 USD - $122,603 USD. The actual salary depends on professional background, training, work experience, location, business needs, market demand, and competitive market practice.

Benefits

• Competitive pay plus performance-based incentive programs.
• Company-paid Life, Short-Term, and Long-Term Disability Insurance.
• Medical, Dental, and Vision insurance.
• FSA, DCARE, Commuter Benefits.
• Supplemental Life, Hospital, Critical Illness, and Legal Insurance.
• Health Savings Account.
• 401(k) Retirement Plan (Employer Matching benefit).
• Paid Time Off (Rollover Option) and Holidays.
• As Needed Sick Time.
• Tuition Reimbursement.
• Team Social Activities (We have fun!).
• Employee Recognition.
• Employee Referral Program.
• Paid Parental Leave and Bereavement.