Senior Process Engineer (Manufacturing Support)

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
This position provides engineering and automation services with front line, on the floor support for the manufacture of our products for our patients. The engineer collaborates with all customers on site and facilitates the delivery of solutions based on customer needs. The engineering solutions provided need to be safe and effective using current and innovative technology.
This position is responsible for the design and implementation of manufacturing processes, instrumentation and equipment start-ups from the laboratory through manufacturing scale of facilities, utilities, systems and equipment. This individual provides expertise in cell culture and purification process equipment and supporting utilities for biotechnology manufacturing.
This individual is responsible for the creation, management and execution of engineering life cycle documentation and verification (i.e. commissioning through qualification) for manufacturing systems for the NNUSBPI site and manage projects as required. The position is expected to have a solid understanding of good engineering practice (GEP) industry standards, science and risk-based verification requirements and is required to supply support/technical knowledge for the development/refinement and implementation of the GEP program and validation standards based on risk-based practices as prescribed in ASTM E2500. Also, will work with NNUSBPI leadership to manage and create group strategy and systems, allocating resources to projects, managing timelines for projects and developing the talent within the department.
Relationships
Reports to: Lead Engineer
Number of subordinates with direct/indirect referral: none
Essential Functions

• Incorporates the Novo Nordisk Way and 10 Essentials in all activities and interactions with others
• Leads process and equipment troubleshooting on the manufacturing floor to support product supply, deviations, corrective actions and related issues
• System owner for manufacturing systems (i.e. facilities, utilities, systems and equipment) and associated life cycle documentation and procedures
• Contribute to long-term strategic development of the engineering and verification program
• Technically independent and maintains up-to-date knowledge of industry standards and regulatory compliance requirements and independently contributes to the development of the Engineering Team and contributes to the development of best practices
• Coordinate fabrication, procurement, installation, engineering start-up, and validation activities of new equipment and systems
• Lead 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 or user representative for contractor services including design, fabrication, installation and validation
• Point person for process improvement activities
• Responsible for authoring equipment specifications, user and functional requirements specifications, and necessary verification documents (e.g. FAT, SAT, commissioning, qualification protocols). Leads the preparation and execution of protocols, data analysis and final reporting
• Initiate and manage projects, tracking spending of budgets, creating scope of work, justification, risk assessments, cost estimates, implementing purchase order requisitions, and controlling payment schedules
• Regular supervision of contractors for projects
• Organizes and presents (either written or verbally) their work
• Independently analyses and interprets data with limited consultation with supervisor, makes independent tactical decisions based on data, develops project strategies with consultation with supervisor
• Contributes to mentoring activities for the development of the Engineering team
• Represents the Engineering department on cross-functional teams
• Independently initiates, designs, and evaluates plans for site projects, responsible for planning and execution of all tasks needed to meet goals. Executes priorities and begins to consider long range project planning with consultation with supervisor, good project and personnel management skills are required
• No supervision for day-to-day activities required, meets regularly with supervisor to update on progress towards long-term goals
• Provides input and direct support during regulatory inspections. Supports health authority and corporate audits
• Implement department action plans based on the results from internal or external audits, CAPA and exception management processes
• Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations and industry codes
• Other duties as assigned

Qualifications

• Education and Certifications:
  • Requires a Bachelors/Master's degree (or equivalent experience) in engineering or related life sciences discipline
• Work Experience:
  • Bachelor's degree with 10 plus years' experience in the pharmaceutical or biotechnology industry, or a Master's degree with a minimum of eight (8) years' experience in the pharmaceutical or biotechnology industry
  • Prefer medium to large scale pharmaceutical or biotechnology process experience

• Knowledge, Skills, and Abilities:
  • A strong understanding of: GEP and Validation concepts, international cGMP regulations, GAMP and other industry standards pertaining to the technical and verification requirements for biopharmaceutical equipment, facilities, and/or instrumentation
  • A strong work ethic (self-motivated) honesty, excellent communication skills, and the ability to work in teams-displays initiative and commitment
  • Engineering and risk-based management within an FDA, EMEA, GMED or TGA regulated production facility
  • Knowledge of GMPs, Compliance and Regulatory requirements is essential
  • Excellent communication skills and ability to work in a high-paced team-oriented environment
  • Off Hours and Weekend Coverage expected for manufacturing support. May be called in on nights and weekends

Physical Requirements
0-10% overnight travel required. 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 analyzing; 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: odors, fumes, and dust.
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we're life changing.
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.
If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.