Commissioning Engineer; Junior - Senior Level

Position: Commissioning Engineer (Junior - Senior Level)
Location: West Lebanon

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 positions

* 36 Paid days off including vacation, sick days & company holidays

* Health Insurance, Dental Insurance, Vision Insurance

* Guaranteed 8% 401K contribution plus individual company match option

* 14 weeks 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?

The Position

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.

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:

Manager, Technical Support

Essential Functions

* 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 activities within Facilities Engineering and point of contact with site Validation Team

* Maintains technical knowledge and current trends within the commissioning process and science and risk-based validation (SRV) programs

* Support commissioning concepts, data and approaches for audits and inspections

* This role may be required to work in cleanroom/sterile areas which may require wearing: hairnet, beard cover, frocks/coveralls, shoe covers, snood, face mask, sterile gloves, and to follow GMP processes at all times. Examples of prohibited materials in cleanroom areas may include (but are not limited to): food/drink/gum, jewelry, cosmetics, nail acrylics, perfume/cologne, and personal cell phones

* 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

* Associate's degree in life science or engineering required

* Bachelor's degree in life science or engineering preferred

* Associate's degree with two (2) years of related experience required

* Bachelor's degree with one (1) year related experience preferred

* Pharmaceutical process or…