Process Engineer Level I-II; Downstream
Listed on 2026-01-06
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Engineering
Quality Engineering, Process Engineer
Location: West Lebanon
Process Engineer Level I‑II (Downstream)
Join the Process Engineer Level I‑II (Downstream) role at Bio Space (Novo Nordisk) and help bring life‑saving treatments to the world. You will be based in West Lebanon, NH and report to the Manager of Process Support (Downstream).
About The DepartmentNov Nordisk’s West Lebanon, NH facility is a state‑of‑the‑art biomanufacturing plant that produces a global supply of hemophilia and growth‑hormone products as well as next‑generation medications. The facility is cGMP‑certified and operates under strict quality, safety, and regulatory standards.
What We Offer You- Competitive salary with annual performance bonus
- 36 paid days off (vacation, sick days, company holidays)
- Health, dental, and vision insurance
- 8 % 401(k) match plus optional additional match
- 14 weeks paid parental leave
- Free access to Novo Nordisk‑marketed pharmaceutical products
This role is part of the bioproduction downstream purification process support team. You will provide on‑floor technical assistance, maintain and improve documentation, and support training to run operations according to cGMP requirements. You may also assist with designing and implementing manufacturing processes, instrumentation, and equipment start‑ups from the laboratory to full scale. The Process Engineer will closely work with Process Associates and Process Scientists to resolve day‑to‑day issues such as deviation investigations, CAPAs, equipment troubleshooting, small‑scale process development, SOP review, and process confirmations on the shop floor.
EssentialFunctions
- Assist with the development, revision, and maintenance of SOPs, JIs, DVs and other production documentation.
- Participate in the design and implementation of process and automation improvement changes.
- Help drive minor improvement initiatives and support colleagues on improvement projects.
- Draft and support documentation for production, trend reports, and complex cases; present findings during audits/inspections.
- Maintain effective communication and coordination with appropriate teams to ensure timely delivery of activities.
- Ensure validated state of systems and processes in accordance with FDA, EU, and Novo Nordisk requirements.
- Actively participate in cross‑functional teams to identify root causes and corrective actions.
- Write and review protocols, summary reports, and other documentation related to ongoing production, verification, and validations.
- Coordinate scheduling of improvement and critical production activities across areas and with outside vendors.
- Represent the Manufacturing department in cross‑functional teams and present relevant material during audits/inspections.
- Participate in on‑call rotations, including weekends and non‑business hours.
- Perform all job duties in a compliant and ethical manner in accordance with healthcare laws and industry codes.
- Integrate Novo Nordisk Way and 10 Essentials in all activities.
- Provide additional duties as assigned.
- Bachelor’s degree in engineering or a related discipline (required).
- At least three (3) years of related experience (required).
- Experience in medium to large‑scale pharmaceutical or biotechnology processes preferred.
- Strong knowledge of automation and GMP requirements preferred.
- Broad understanding of science and risk‑based verification (e.g., ASTM E2500).
- Knowledge of good engineering practices.
- Excellent written and verbal communication skills.
- Ability to provide evening, nighttime, and weekend on‑call support as needed.
- Technical knowledge of validation of biopharmaceutical equipment, facilities, and instrumentation preferred.
- Responsiveness during on‑call periods (support within 60 minutes).
- Ability to climb, stoop, kneel, crouch, crawl, reach, stand, and walk.
- Capability to push, pull, lift, and grasp objects up to 33 lbs (15 kg) occasionally, 30 lbs frequently, or 10 lbs constantly.
- Repetition of wrist, hand, or finger movements.
- Visual acuity sufficient for reading, writing, analyzing, and inspecting work.
- Work environment may include noise, narrow aisles, temperature variations, fumes, and dust.
- Local and international travel: 0‑10 %.
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
Nov Nordisk is an equal‑opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status, or any other characteristic protected by local, state, or federal laws.
If you need assistance or accommodation to apply, please call 1‑855‑411‑5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.
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