Process Engineer

About the position

Responsible for assisting with design and implementation of manufacturing processes, instrumentation and equipment start-ups from the laboratory through manufacturing scale. Our West Lebanon, NH site is a commercial biologics manufacturing facility and this role will assist with manufacturing systems and equipment onsite.

Responsibilities

• Assist with coordinating fabrication, procurement, installation, engineering start-up, verification and validation activities of new equipment and systems.
• Participate in the development and implementation of procedural or automation improvement changes.
• Participate in design and hazard reviews of plant expansions or process changes.
• Support person for process improvement activities; including performing or authoring equipment specifications, user and functional requirements specifications, and necessary FAT and SAT protocols.
• Maintain effective communication and ensure alignment in coordination with appropriate teams.
• Support facility certification for new Manufacturing and Quality Control facilities as needed.
• Ensures systems and processes are verified and validated in a compliant manner in accordance with FDA, EU and NN requirements.
• Actively participate on cross functional teams to determine the root cause and corrective actions for problems associated with investigations.
• Completes accurate and timely assessments associated with change control activities.
• Ensures change control activities for systems are completed in a manner in compliance with FDA, EU and NN regulations.
• Responsible for the verification of new and existing equipment, processes and instrumentation as needed.
• Write and review protocols, summary reports and other documentation associated with verification, and validations.
• Coordinate scheduling of verification activities within Novo Nordisk US Bio Production, Inc. as well as with outside vendors as needed.
• Represent the Manufacturing Engineering department on cross-functional teams.
• Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations and industry codes.
• Incorporates the Novo Nordisk Way and 10 Essentials in all activities and interactions with others.

Requirements

• Requires a Bachelor's degree in engineering or related discipline.
• A minimum of two (2) years related experience, preferably in medium to large scale pharmaceutical or biotechnology process experience.
• Ability to follow routine work instructions for new and ongoing projects and assignments.
• Knowledge of Automation and GMPs requirements preferred.
• Broad understanding of science and risk-based verification (I.E. 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 requirements for Validation and of biopharmaceutical equipment, facilities and/or instrumentation preferred.

Benefits

• Leading pay and annual performance bonus for all positions.
• 36 Paid days off including vacation, sick days & company holidays.
• Health Insurance, Dental Insurance, Vision Insurance.
• Guaranteed 8% 401K contribution plus individual company match option.
• 14 weeks Paid Parental Leave.
• Free access to Novo Nordisk-marketed pharmaceutical products.