Commissioning Engineer (Junior - Senior Level)
Novo Nordisk
4 days ago
On-site
West Lebanon, NH
Operations
Benefits (explicit):
- 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
The Position:
- 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
Essential Functions:
- 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
Qualifications:
- 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
Skills/Abilities (required & 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
Onsite: Monday–Friday at bioproduction facility in West Lebanon, NH. Local/International travel: 0–10%.
- 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
The Position:
- 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
Essential Functions:
- 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
Qualifications:
- 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
Skills/Abilities (required & 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
Onsite: Monday–Friday at bioproduction facility in West Lebanon, NH. Local/International travel: 0–10%.