Engineering Responsible

Are you experienced in establishing relevant engineering methods and processes? Do you want to be part of a team that works to implement and validate all efforts and investments to increase the capacity within our facilities? Are you a person that looks for smarter ways of doing things? If above questions sounds like you, and you want to contribute to [xxxxx]’s growth and bid to provide care for more patients, apply now!
What qualifications we look for
As ER your background should reflect a basic knowledge and/or expertise within:

Master or Bachelor degree in Computer Science, Engineering, or other relevant studies

Experience with Good Engineering Practice (GEP): engineering and technical industry standards (e.g. ISPE, ASTM, PDA, ISO) supported by authority requirements e.g. GMP, GDP, HSE, and building regulations for process/ system in scope in systems such as: Track and Trace - Serialisation system (PexCite), ESXi (VmWare), Virtual Machines, MS SQL, SCOM, TIMS, MES systems – PasX, SAP ATTP/PO/ECC, PLCs

Knowledge of technical disciplines (as relevant): e.g. HVAC, Mechanical, Process, Automation, build, utilities

Contract management: e.g. supplier assessment, supplier selection, supervision and scope management

Experience within compliance, validation and GxP environment is an advantage

Note: If not all competencies are in place for a specific project the ER can be supported by Technical experts (TE), other ERs and/or Operation Responsibles (OR) as relevant. Let’s talk about the role
As Engineering Responsible (ER) you will use your subject matter expertise within Good Engineering Practice (GEP) to establish relevant engineering methods and processes throughout a project. The focus in our team is to support strategic initiatives by delivering OT/Automation solutions and services for our production facilities. You will be involved in all phases of a project until hand-over to operation. Often the ER is the main driver of the activities from the project planning phase until operational verification (OV).
While having responsibility to deliver effective solutions of processes/systems that are: fit for intended use, operationally sustainable and within cost and quality requirements, you will work closely together with other roles such as: Operation Responsible(OR), QA and if relevant Technical experts and vendors/consultants. In some cases, you will be assigned as Project Manager and/or Work package Owner (WPO) during a project until hand-over. Hereafter the OR will take over as main driver and the ER will take a support role until hand-over. Furthermore you are involved in discontinuation projects with focus on decommissioning activities. Your daily tasks and responsibilities will be to:

Lead and participate in validation projects as supporter/responsible

Work collaboratively across functions with Quality Assurance, Line of Business and vendors to plan, coordinate and execute validation activities

Perform Science and Risk-based validation of infrastructure within our facilities

Participate in Progress Groups across areas in Novo Nordisk to ensure we always apply best practice in our processes

Facilitate verification and validation activities including test execution, documentation review and approval

The Engineering Responsible collaborates with internal and external stakeholders to ensure the successful execution of projects and the maintenance of technology infrastructure across different regions. The ER role involves managing dynamic projects with travel to vendor and production sites in various countries, including Germany, France, Brazil, the US, China, and Denmark. The team waiting for you
Being part of wider organization of Digital Data & IT Product Supply,Production, in our Operational Technology Enabler Center of Excellence (OTE CoE) we are on the brink of a transformative journey towards being a CoE. The Serialisation Production team is located in Bagsværd and our newly renovated and established DD&IT campus where we work 1 day a week sits in Ballerup (Greater Copenhagen area), Denmark. Digital, Data & IT Product Supply, Production is anchored within the Digital, Data & IT organisation and has approx. 4.000 employees based in Denmark, India, US, China, France, and Brazil. The strategic objective of the unit is to be the IT partner for the business, ensuring that we provide the IT solutions and support the [xxxxx] production solution needs worldwide. The focus in our team is to support strategic initiatives by delivering OT/Automation solutions and services for our production facilities. Our team is characterized by team spirit, innovation, quality mindset and a trust based working environment. Contact
For further information, please contact People Leader, Lena Jensen +[xxxxx].

Deadline
20 June 2024

You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your CV. Please submit English version of your CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At [xxxxx] we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.