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 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 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%. #J-18808-Ljbffr Scorpion Therapeutics