Downstream Purification Process Engineer II – GMP

BioSpace

West Lebanon (NH)

On-site

USD 100,000 - 140,000

Full time

12 days ago

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Job summary

Novo Nordisk's West Lebanon site in New Hampshire seeks an onsite Process Engineer to support production, drive process improvements, and lead projects from lab scale to manufacturing scale. You will work with Process Associates, Engineers and Scientists to optimize processes and ensure quality.

The role requires collaboration across Manufacturing, Engineering, Technical Support and Quality, with strong knowledge of GMP and regulatory expectations. Local travel and on‑site presence are expected.

Qualifications

  • Bachelor’s degree in engineering or related discipline required.
  • Master’s degree in engineering or related discipline preferred.
  • Five (5) years of related experience with a bachelor’s degree; three (3) years with a master’s degree preferred.
  • Knowledge of Automation, GMPs, Compliance and Regulatory requirements is essential.

Responsibilities

  • Leads process and equipment troubleshooting to support deviations, corrective actions and related issues.
  • Ensures systems and processes are verified and are kept in a validated state in accordance with FDA, EU and NN requirements.
  • Participate in the development and implementation of procedural or automation improvement changes.
  • Participate in design and hazard reviews of plant expansions or process changes and serving as the technical point of contact for contractor services.
  • Plan and execute according to timeline and in a compliant manner and ensure timely deliveries of own activities.
  • Active participation in cross functional teams to determine root cause and corrective actions for investigations.
  • Coordinate scheduling of improvement and critical production activities within own area and with outside vendors.
  • Support validation of new and existing equipment, processes and instrumentation.

Skills

GMP knowledge
Excellent communication
Cross-functional teamwork

Education

Bachelor’s degree in engineering
Master’s degree in engineering

Job description

Novo Nordisk's West Lebanon site in New Hampshire seeks an onsite Process Engineer to support production, drive process improvements, and lead projects from lab scale to manufacturing scale. You will work with Process Associates, Engineers and Scientists to optimize processes and ensure quality.

The role requires collaboration across Manufacturing, Engineering, Technical Support and Quality, with strong knowledge of GMP and regulatory expectations. Local travel and on‑site presence are expected.

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