Senior Process Engineer- API Manufacturing

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?

For this position we are seeking a Senior Process Engineer with experiene with Active Pharmaceutical Ingredients (API). 
 

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.

 

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 evaluate