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 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 or user representative for contractor services including design, fabrication, installation and validation
• Plan and execute according to timeline and in a compliant manner and ensure timely deliveries of own activities
• Actively participate in cross functional teams to determine the root cause and corrective actions for problems associated with investigations
• Write and review protocols, summary and trend reports and other documentation associated with ongoing production, verification and validations
• Coordinate scheduling of improvement and critical production activities within own area, across areas and as well as with outside vendors as needed
• Support validation of new and existing equipment, processes and instrumentation as needed
• Represent the Manufacturing department in cross-functional teams (Manufacturing, Engineering, Technical Support and Quality groups) and present relevant material during audits/inspections
• Own equipment and process in the production area and keep these within compliance
• 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 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 environment
• Participate in on-call rotations, including weekends and non-business hours, to provide support
• 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
• Other duties as assigned

Qualifications

• Education and Certifications:
  • Bachelor's degree in engineering or related discipline required
  • Master's degree in engineering or related discipline preferred
• Work Experience:
  • Bachelor's degree with five (5) years of related experience required
  • Master's degree with three (3) years of related experience preferred
  • Medium to large scale pharmaceutical or biotechnology process experience preferred
• Knowledge, Skills and Abilities:
  • Normally receives no instructions on routine work, general instructions on new assignments
  • Knowledge of Automation, GMPs, Compliance and Regulatory requirements is essential
  • Excellent communication skills and ability to work in a high-paced team-oriented environment
  • Employee 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%.