The Purpose

Responsible for supporting projects for implementation of manufacturing projects within our GMP bioproduction facility, this role will support our project management team with a variety of capital & operational excellence projects. 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 report into our Project Engineering team and work cross functionally across the site to support ongoing projects, and will work with external vendors and contractors as needed.

This role is based onsite 5 days a week at our West Lebanon, NH bioproduction facility.

Relationships

Reporting to: Sr. Manager of Project Engineering

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
• 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%