Commissioning Engineer; Junior - Senior Level

Benefits

• Leading pay and annual performance bonus for all positions
• 36 Paid days off including vacation, sick days & company holidays
• Health, Dental, and Vision Insurance
• Guaranteed 8% 401K contribution plus individual company match option
• 14 weeks Paid Parental Leave
• Free access to Novo Nordisk-marketed pharmaceutical products

Support commissioning activities: analysis, authoring protocols, and commissioning new/existing equipment, processes, and instrumentation per science & risk-based validation (SRV).

Provide input across specification setting, supplier selection, and commissioning/qualification/verification.

Develop requirements; build/construct/design; perform SAT and FAT verification; support pharmaceutical manufacturing commissioning (requalification, cleaning, sterilization, utilities).

Collaborate with production and stakeholders to ensure deliverables.

• Maintain proficiency in Facilities, Utilities, Systems, and equipment operations.
• Create/execute commissioning protocols; perform data analysis and final reporting.
• Ensure commissioning/system record accuracy and compliance.
• Partner with Validation Department; review protocols/summary reports/documentation (Specifications, SOPs).
• Support deviations (DV) and change requests (CR); provide data for change control assessments.
• Support facility certification for new/upgraded manufacturing and QC facilities; ensure compliance with FDA/EMA/NN requirements.
• Represent Facilities Engineering as SME for commissioning; maintain SRV knowledge.
• Support audits/inspections; comply with GMP and cleanroom requirements (PPE) as needed.

• Associate’s degree in life science or engineering required.
• Bachelor’s degree preferred.
• Associate’s degree with 2 years related experience required;
  Bachelor’s with 1 year preferred.
• Pharmaceutical process/biotechnology experience preferred.

• Data analysis and report writing.
• Understanding of validation/commissioning; change control processes.
• Root cause analysis and cGMP documentation practices preferred; cGMP regulations preferred.
• Excellent written/verbal communication; strong teamwork and independent work.

Monday–Friday at bioproduction facility in West Lebanon, NH. Local/International travel: 0–10%.