Design Control Engineer/Specialist

Found in: beBee S DK - 3 weeks ago

Valby, Denmark Lundbeck Pharma AS Full time

Design Control Engineer/Specialist - CMC Biologics Device area

Are you experienced with Design Control and looking to join our growing team of Device and Combination Product Experts? And do you want to work with devices and combination products in an international setting where empowerment and cross functional collaboration skills are key? Then you might be our new Design Control Engineer/Specialist

Lundbeck has several development projects in pipeline requiring combination products with a device constituent part. We implemented first generation fit-for-purpose Quality Management System (QMS) and are in the phase of maturing our setup to support the future combination product development activities within Lundbeck.

The position provides a unique and rare opportunity for you to be part of building and shaping the future.

Your new role why is this a great opportunity?

As our Design Control Engineer/Specialist, you are part of the project teams focusing on the device constituent and contributing to establishing, reviewing, and maintaining project documentation with focus on e.g. requirements, specifications, verifications, design transfers, control strategies for system and module level and cooperations with external partners. You will also be an instrumental part of continuously developing and maturing our device organisation, working procedures (QMS) and tools, this in parallel with delivering on project activities. You will work in close collaboration with colleagues across the organisation.

In CMC Biologics, you will be responsible or contribute to and facilitate a wide range of activities (for the Combination Product and Device Constituent Part) adjusted according to your interest and capabilities:

General project documentation (Design Control documentation) Design reviews (Lundbeck, vendors and CMOs) Definition of system and module requirements System Design Verification in collaboration with systems engineer and risk manager Module Design Verification in collaboration with vendors Defining and maturing Combination Product Control Strategy Defining and maturing Manufacturing Control Strategy in collaboration with vendors, systems engineer, and QA Design Transfer to CMO and internal manufacturing site (specifications and agreements) Implementation of Incoming Control, Process and Release Specifications Process Validation covering Device Constituent Part in cooperation with our validation team Technical complaint handling Technical files (IND/CTA/BLA) Supporting regulatory filings and other interactions with Health Authorities Collaborate with Drug Product colleagues in department and project teams to define interfaces between drug constituent and device constituent

This position is a unique professional development opportunity, as you will be part of a cross functional team/area providing you the option to learn from other disciplines (like Drug Product) in an international environment, while building on your current skills within Combination Products.

You will be part of defining future device options, development, and supply chain strategies of Device Constituent Parts within Lundbeck and work in an exciting interface with various internal and external stakeholders.

Your future team

The device and combination product development is the responsibility of the Drug Product Technology department, which is a part of CMC Biologics. In CMC Biologics we are more than colleagues, split between Lundbeck Headquarters in Copenhagen, Denmark and Lundbeck Center of Excellence in Seattle, US. Drug Product Technology is also split between the two sites (approx. 75/25), where all device resources are based in Copenhagen.

Your colleagues in the Drug Product Technology team are all experienced Device or Drug Product specialists, and together we cover Device Constituent Part and Drug Constituent Part forming the Combination Products for all Lundbeck biologics projects.

In Lundbeck, we aim to develop new innovating treatments to improve the lives of patients living with brain diseases. CMC Biologics support the development and production of new Biologics drug candidates for diseases like Migraine, Parkinsons, and Alzheimers. Established CMC Biologics focus teams and working groups are responsible for the continued development of Lundbecks Biologics candidates to successful marked launch. We are working into global cross functional project teams with representatives from R&D, Preclinical and Clinical Development, Regulatory Affairs, QA, and Commercial.

Our area is rapidly growing, and we need every brain in the game to succeed with our expanding portfolio. Thus, this is a unique opportunity for personal and professional development, as we actively avoid working in silos and focus on being widely engaged in the projects.

Business travels to partners in Europe, United States and Asia are to be expected (estimated 10-20 days per year). As our team is located both in Copenhagen and Seattle and our vendor network is global, we need to accommodate to time zone differences when we have department or vendor meetings etc. We aim to reduce late meetings by maintaining a primary meeting band in the calendar, this combined with a flexible workday to compensate for potential late meeting hours.

What you bring to the team

You preferably bring 3+ years of experience working with device constituents and combination products. You hold a Bachelor, Master or PhD in engineering or similar academic education. Furthermore, you have the following skills:

Good stakeholder management skills Good collaboration skills and ability to understand the agendas in Commercial, Regulatory Affairs, Quality Assurance, Global Patient Safety, Clinical Development, and Product Supply etc. Ability to independently plan and proactively handle multiple tasks simultaneously Knowledge and understanding of device and combination product regulations (MDR, 21 CFR Part 4, 21 CFR //, etc.) Knowledge and understanding of device and combination product standards (e.g., ISO , ISO -series, ISO , IEC -1 etc.) Interest in establishing and maturing ways of working by authoring and reviewing Standard Operating Procedures (SOPs)

Candidates fulfilling some but not all the listed qualifications are encouraged to apply, as the position will be adjusted according to qualifications.

Our promise to you

Lundbeck offers an inspiring workplace, passionate colleagues and a culture characterized as collaborative a must to bring our treatments through research and development all the way to commercialization and the people who need them. We offer a mix of exciting tasks and numerous development opportunities that are balanced with initiatives focused on your well-being.

Apply now

Can you see yourself as our new Design Control Engineer/Specialist and want to join our international team of Device and Drug Product Specialists?

Then upload your CV and include your motivation for applying. No separate cover letter is needed. We ask you not to include a photo or personal information that does not relate to your professional experience.

Applications must be received by April 30, and will be reviewed on an ongoing basis.

#EveryBrainInTheGame

This job ad is intended for individuals seeking a career opportunity with Lundbeck. We engage with recruitment and search firms where needed on the basis of a written agreement, and we do not accept unsolicited requests of any kind. If you work as a recruitment consultant, you are kindly instructed to refrain from contacting Lundbeck or the hiring manager directly with suggested candidates. If you violate this policy, you do so at your own risk and for your own account, and Lundbeck will not assume any liability nor pay any associated fees resulting from such violation.

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