Technical Specialist - Engineering Systems

About The Department

You will be joining Fill & Finish Expansions (FFEx), which is responsible for all major expansion activities within aseptic production, solid dosage forms, finished products, fill & finish warehousing, and QC across all production areas in Product Supply. The area is anchored in Product Supply, Quality & IT, which globally employ approx. 20,000 of Novo Nordisk’s 50,000 employees. FFEx is a newly established and growing area with the responsibility to design, plan, and build all new aseptic filling capacity across Novo Nordisk to serve the needs of millions of patients. We do it by rethinking our production facilities with the use of modern technology, as we are setting the standards for the aseptic production of the future. Facilities designed today which we will still be proud of 20 years from now. FF Expansions has a global approach, where you will be working with multiple sites and cultures across the world.

The Position

Serve as Subject Matter Expert (SME) and provide administrator-level knowledge of various electronic engineering systems including EDMS, BIM, Procore, EIDA, ACC, etc. from a functional perspective. The position is the liaison between other internal stake holders such as the FFEx core team, QA, IT and external contractors where necessary to facilitate engineering systems control. The strategic direction and technical expertise provided by this role will drive project success and foster a culture of innovation and continuous improvement.

Essential Functions

• Provide technical expertise to the engineering team as it relates to electronic engineering systems
• Lead and provide guidance to evaluate, implement, and validate a robust EDMS capable of handling a variety of document types
• Serve as the technical expert related to electronic engineering systems projects
• Define and support the achievement of department goals according to company objectives and strategies
• Propose, guide, and evaluate solutions for process/maintenance changes and continuous process improvements
• Implement new technologies for the process/maintenance, planning and coordinating of changes according to applicable regulatory procedures
• Identify and mitigate potential risks and challenges in projects
• Facilitate problem solving, investigations, and process improvements
• Collaborate with internal stakeholders to integrate Engineering Systems with other and existing systems. Ensure seamless data flow and optimize system interoperability
• Create governance structure including procedures for Engineering Systems
• Responsible for system administration, system upgrades and enhancements, user support, and continuous improvement
• Create governance structure including procedures for Engineering Systems
• Present as the technical expert for assigned processes to auditors/inspectors regarding complex subject matter
• Aid in preparing and managing engineering budgets

Physical Requirements

• Ability to work in an open office environment with the possibility of frequent distraction
• Ability to travel up to 10% of the time (% can change on a case-by-case basis based on the role)

Qualifications

• Bachelor’s degree in engineering or related field of study from an accredited university required
• May consider an associate’s degree in engineering technology or related field of study from an accredited university with a minimum of ten (10) of manufacturing experience required, preferably in a pharmaceutical or life sciences industry
• May consider a High School Degree or equivalent with a minimum of twelve (12) years of manufacturing experience required, preferably in a pharmaceutical or life sciences industry
• Minimum of eight (8) years of manufacturing experience required, preferably in a pharmaceutical or life sciences industry
• Ability to read, write and understand complicated product documentation and standard operating procedures with attention to high-level concepts required
• Excellent written communication skills, investigative writing, and computer skills (MS Word, Outlook, Excel, PowerPoint, Access, SAP) required
• Strong technical knowledge of Engineering Systems including EDMS, BIM, CAD, COMOS, Procore, EIDA, Aconex, etc. required
• Proficiency in web technologies, database management, and systems integration preferred
• Demonstrated ability to shape and execute a strategy in a complex international environment preferred
• Solid understanding of cGMP’s and 21 CFR Part 11 requirements, quality management including principles for validation of equipment, utilities, and facilities required
• Recent project execution experience, successfully led large and complex global GxP investments projects required
• Up to date knowledge of industry trends, best practices, and regulatory requirements related to Engineering Systems required