Overview
Commissioning Engineer; Junior – Senior Level Jobs in Dover, USA at Scorpion Therapeutics
Position: 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%.
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Title: Commissioning Engineer; Junior – Senior Level
Company: Scorpion Therapeutics
Location: Dover, USA
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