Process Engineer I - Biotech Manufacturing

Initial Therapeutics, Inc.; West Lebanon (NH); On-site; USD 95,000 - 125,000; Full time

Benefits offered by this job

Annual bonus

Health insurance

Dental insurance

Vision insurance

401K with match

Parental leave 14 weeks

Product samples

Job summary

Novo Nordisk in West Lebanon, NH is seeking a Process Engineer to support production on the shop floor, ensuring cGMP compliance and accurate documentation. The role includes training technicians, participating in CAPAs and investigations, and coordinating process improvements across multiple teams.

The ideal candidate has a bachelor’s degree in engineering and 3+ years in biopharma processes, with strong communication skills and the ability to work alternating on-call hours.

Qualifications

• Bachelor’s degree in engineering or related discipline required.
• 3+ years related experience in pharmaceutical/biotech process preferred.
• Knowledge of GMPs and regulatory requirements (FDA/EU) preferred.
• Excellent written and verbal communication skills.
• Ability to work in a high-paced team-oriented environment and on-call support.

Responsibilities

• Assist with SOPs, JIs, DVs and other production documentation for shopfloor.
• Participate in development and implementation of procedural or automation improvements.
• Support day-to-day shopfloor issues and equipment troubleshooting.
• Write/review protocols, summaries and trend reports for ongoing production, verification, and validations.
• Coordinate scheduling of improvements within area and with outside vendors as needed.
• Represent Manufacturing in cross-functional teams and present material during audits.
• Participate in on-call rotations, including weekends.

Skills

cGMP knowledge

Documentation

Cross-functional collaboration

On-floor manufacturing support

Training and SOP development

Education

Bachelor’s degree in engineering

Tools

Automation systems

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.

What we offer you:

• Leading pay and annual performance bonus for all positions36Paid days off including vacation, sick days & company holidaysHealth Insurance, Dental Insurance, Vision InsuranceGuaranteed 8% 401K contribution plus individual company match option14weeks Paid Parental LeaveFree access to Novo Nordisk-marketed pharmaceutical products

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. This role will be part of our bioproduction downstream purification Process Support team, dedicated to one of our manufacturing suites. Responsible for supporting production through on-floor knowledge and support, documentation to keep production running efficiently, supporting training of technicians to run according to cGMP requirements, ensuring routine preventative maintenance and equipment repairs are carried out correctly. May be responsible for assisting with broader 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

• Assist with SOPs, JIs, DVs and other production documentation to the shopfloorParticipate in the development and implementation of procedural or automation improvement changesParticipate in production-driven improvements to the process and equipment on shopfloor. Drive an own minor improvement initiative and support colleaguesDevelop, write and support any documentation needed in the production as well as supporting trend reports and complex cases owned by the area. Presents this during audits/inspectionsMaintain effective communication and ensure alignment in coordination with appropriate teamsPlan and execute according to timeline and in a compliant manner and ensure timely deliveries of own activitiesEnsures systems and processes are verified and are kept in a validated state in accordance with FDA, EU and NN requirementsActively 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 neededRepresent the Manufacturing department in cross-functional teams (Manufacturing, Engineering, Technical Support and Quality groups) and present relevant material during audits/inspectionsParticipate 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

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%.

Qualifications

• Education and Certifications:Bachelor’s degree in engineering or related discipline required

Work Experience:Bachelor’s degree with three (3) years related experience requiredMedium to large scale pharmaceutical or biotechnology process experience preferredKnowledge, Skills, and Abilities:Ability to follow routine work instructions for new and ongoing projects and assignmentsKnowledge of Automation and GMPs requirements preferredBroad understanding of science and risk-based verification (I.E. ASTM E2500)Knowledge of good engineering practicesExcellent written and verbal communication skills a mustExcellent communication skills and ability to work in a high-paced team-oriented environmentAbility to provide evening, nighttime, and weekend on call support as neededTechnical requirements for Validation and of biopharmaceutical equipment, facilities and/or instrumentation preferredEmployee must remain accessible during on-call period and must be able to provide support/respond within sixty (60) minutes

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.