Commissioning Engineer; Associate - Level II

Commissioning Engineer (Associate - Level II)

Location:

West Lebanon, NH, US

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.

• Leading pay and annual performance bonus for all positions
• 36
  
  Paid days off including vacation, sick days & company holidays
• Guaranteed 8% 401K contribution plus individual company match option
• 14weeks Paid Parental Leave
• Free 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?

This position will support commissioning activities providing analysis, authoring protocols and commissioning new and existing equipment, processes and instrumentation in accordance with science and risk-based validation (SRV). This role will provide input to project team members through all stages of specification setting, supplier selection and commissioning / qualification /verification. This role will also help develop requirements, build/construct, design, commission, perform SAT and FAT verification activities for projects according to (SRV) and approved timelines.

This work may include commissioning within pharmaceutical manufacturing such as: requalification, cleaning, sterilization and utilities. Collaboration with production, production support groups and other stakeholders to ensure completion of deliverables. Prior experience in a GMP or Life Science environment is preferred.

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.

Reports to:

Sr. Manager, Project Engineering

• Maintains proficiency and understanding of Facilities, Utilities, Systems and equipment operations
• Author and participate to complete commissioning protocols and execution, data analysis and final report preparation for utilities, equipment and instrumentation. This may include site acceptance testing (SAT) and factory acceptance testing (FAT)
• Supports consistent and best practices for creating and executing commissioning protocols
• Ensures accuracy and compliance of commissioning and system records
• Partner with the Validation Department to participate and provide feedback to NN validation process group
• Ability to work and communicate effectively across multiple local departments. multiple international production sites
• Support the creation and review of documentation (Specifications, SOPs, etc.) in accordance with local, NN and regulatory requirements
• Supports Deviations (DV) and Change requests (CR) related to commissioning activities
• Maintain effective communication and ensure alignment in coordination with appropriate teams
• Support facility certification for new or upgraded Pharmaceutical Manufacturing (process equipment and facility-support equipment) and Quality Control facilities as needed and the continued operation of such facilities
• Ensures systems and processes are commissioned in a compliant manner in accordance with FDA, EMA and NN requirements
• Represent Facilities Engineering and actively participate with cross-functional teams (Validation, Manufacturing, Engineering, Facilities and Quality groups) related to commissioning and validation
• Provide data for assessments associated with change control activities
• Review protocols, summary reports and other documentation associated with commissioning
• Serves as Subject Matter Expert (SME) for commissioning…