Process Engineer II - III (Downstream Purification)

Initial Therapeutics, Inc.; West Lebanon (NH); On-site; USD 90,000 - 130,000; Full time

Job summary

Novo Nordisk is seeking an on-site Process Engineer at our West Lebanon, NH bioproduction facility. The role focuses on supporting production, leading improvements, investigations, and validated state maintenance to ensure compliant operations.

The position emphasizes collaboration with Process Associates, Engineers and Scientists to drive design, equipment start-ups, and process enhancements from lab to manufacturing scale, while adhering to safety and quality standards.

Qualifications

• Bachelor's degree in engineering or related discipline required.
• Master's degree in engineering or related discipline preferred.
• Knowledge of Automation, GMPs, Compliance and Regulatory requirements is essential.
• Ability to work in a fast-paced, cross-functional team environment.

Responsibilities

• Lead process and equipment troubleshooting to support deviations and CAPAs.
• Support validation and qualification of new/existing equipment and processes.
• Collaborate across Manufacturing, Quality, Engineering and Tech Support.
• Mentor contractors or interns and participate in on-call rotations as needed.
• Maintain compliance with FDA, EU, NN requirements and SOPs.

Skills

Automation

GMPs

Regulatory knowledge

Communication skills

On-call support

Education

Bachelor's degree in engineering

Master's degree in engineering

Job description

About the Department

Site New Hampshire, located in West Lebanon, is where Novo Nordisk's life-saving treatments are brought to life. Our manufacturing facility produces a global supply of our hemophilia and growth hormone product lines, as well as our next generation of cutting-edge medications. It's not your average production site - it's a tight-knit, supportive community working together to contribute to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a patient-focused mindset guides everything we do. We're looking for individuals who are self-starters with a strong work ethic to join our team. At Novo Nordisk, you will find opportunities, resources and mentorship to grow and build your career. Are you ready to realize your potential?

The Position

Responsible for supporting production through on-floor knowledge and support, documentation to keep production running efficiently and supporting training of technicians to run according to cGMP requirements. Develop ideas and improvements for the production process and equipment - individually and via close collaboration with colleagues and stakeholders. Participate in and drive production related projects and improvements to support optimizations and capacity improvements as well as complex investigations across Departments. This role will be part of our bioproduction downstream purification Process Support team, dedicated to one of our manufacturing suites. Will be expected to independently lead and execute projects for design and implementation of manufacturing processes, instrumentation and equipment start-ups from the laboratory through manufacturing scale. The Process Engineer will work alongside Process Associates, Process Engineers, and Process Scientists; and may support day to day issues in manufacturing such as: deviation investigations, CAPAs, equipment troubleshooting, small scale process development, SOP review, escalating complex issues to appropriate stakeholders, or participating in process confirmations on the shop floor. This role will work cross functionally with groups/departments across our site to ensure operational efficiencies and successful production of API onsite. This role will require entering our sterile cleanroom areas while following all relevant gowning, safety, and quality policies. Prior experience in a GMP environment or life science industry is a plus for this role.

The job level and title of hired candidate will be commensurate with experience. This is an onsite based position Monday-Friday at our bioproduction facility in West Lebanon, NH.

Relationships

Reports to Sr. Manager, Process Support

Essential Functions

• Leads process and equipment troubleshooting to support deviations, corrective actions and related issuesEnsures systems and processes are verified and are kept in a validated state in accordance with FDA, EU and NN requirementsParticipate in the development and implementation of procedural or automation improvement changesParticipate in design and hazard reviews of plant expansions or process changes and serving as the technical point of contact or user representative for contractor services including design, fabrication, installation and validationPlan and execute according to timeline and in a compliant manner and ensure timely deliveries of own activitiesActively participate in cross functional teams to determine the root cause and corrective actions for problems associated with investigationsWrite and review protocols, summary and trend reports and other documentation associated with ongoing production, verification and validationsCoordinate scheduling of improvement and critical production activities within own area, across areas and as well as with outside vendors as neededSupport validation of new and existing equipment, processes and instrumentation as neededRepresent the Manufacturing department in cross-functional teams (Manufacturing, Engineering, Technical Support and Quality groups) and present relevant material during audits/inspectionsOwn equipment and process in the production area and keep these within complianceInitiate and manage projects, tracking spending of budgets, creating scope of work, justification, risk assessments, cost estimates, implementing purchase order requisitions and controlling payment schedulesRegular supervision of contractor or intern reports including mentoring, performance reviews, project and support advice as well as troubleshooting for the more complicated issues found in the manufacturing environmentParticipate in on-call rotations, including weekends and non-business hours, to provide supportPerforms all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations and industry codesIncorporates the Novo Nordisk Way and 10 Essentials in all activities and interactions with othersOther duties as assigned

Qualifications

• Education and Certifications:Bachelor's degree in engineering or related discipline requiredMaster's degree in engineering or related discipline preferred
• Work Experience:Bachelor's degree with five (5) years of related experience requiredMaster's degree with three (3) years of related experience preferredMedium to large scale pharmaceutical or biotechnology process experience preferredKnowledge, Skills and Abilities:Normally receives no instructions on routine work, general instructions on new assignmentsKnowledge of Automation, GMPs, Compliance and Regulatory requirements is essentialExcellent communication skills and ability to work in a high-paced team-oriented environmentEmployee must remain accessible during on-call period and must be able to provide support/respond within sixty (60) minutes

Physical Requirements

The ability to climb. stoop, kneel, crouch, crawl, reach, stand and walk. The ability to push, pull, lift, finger, feel and grasp. The ability to speak, listen and understand verbal and written communication. Repetition including substantial movement of wrists, hands and or fingers. Lifting up to 33lbs/15kg of force occasionally and/or up to 30 pounds of force frequently and/or up to 10 pounds of force constantly to move objects. Visual acuity to perform close activities such as: reading, writing and analysing; and visual inspection. The working environment includes a variety of physical conditions including noise, inside and outside conditions, working in narrow aisles and temperature changes; atmospheric conditions including: odours, 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.

At Novo Nordisk, we're not chasing quick fixes - we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger - a legacy of impact that reaches far beyond today.

Novo 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, rules or regulations.