Senior Validation Engineer

Summary

The Hillerød Validation Engineering team seeks to recruit a Senior Validation Engineer who will complement the current capabilities of the team and participate in daily operations and expansion/improvement projects.

Job Description

The Validation team is part of Engineering Support, with responsibility for maintaining the validated state of equipment and systems within both the Large-Scale Manufacturing drug substance facility and the Assembly, Label & Pack facility for drug product. This includes qualification of new equipment / systems, chamber validation, cleaning validation and participation in projects / changes.

Main responsibilities

  • Planning and participation in key projects with validation impact

  • Performing and documenting commissioning, IQ, OQ and PQ activities

  • Participating in change control work

  • Planning, executing and documenting all phases of cleaning validation

  • Preparation of annual validation planning / reporting documents for product campaigns

  • Participation in audits and inspections

As the CDMO business at the Hillerød site expands, the Validation team anticipates increased complexity, including new processes and a more diverse product portfolio. Candidates with wide experience and a broad knowledge of regulatory requirements and industry norms are therefore preferred.

The successful candidate will

  • Have good knowledge of inspection agency requirements for equipment qualification

  • Have excellent communication / presentation skills, and be able to articulate complex information to stakeholders and supporting functions such as QC, QA, Engineering, Automation and others

  • Be a team player who works well with colleagues and cross-functional teams

  • Hold a Bachelors or higher degree in a relevant discipline

  • Have at least 10 years’ of relevant industry experience

  • Be conscious of lean ways of working and able to apply risk-based approaches to deliver efficient qualification

  • Be self-starting and have a flexible, dynamic approach to work

  • Bring a friendly, can-do demeanour, professionalism and a good sense of humour

We are screening candidates on a continuous basis so please send your application as soon as possible.

The newly acquired facility located in Hillerød, Denmark brings together a complete range of expertise, capabilities and technologies to reliably manufacture advanced biologics. Our large-scale manufacturing facility manufactures innovative therapies and biosimilars for clinical and commercial use. Our medical device assembly, labeling and packing prepares medicines for delivery to more than 90 countries. The campus is the single-largest foreign greenfield investment in Denmark.

Leveraging our manufacturing excellence, we have gained a deep understanding of what it takes to consistently manufacture advanced biologics. Our manufacturing facility has a capacity of 90,000 liters to produce originator molecules and biosimilars of advanced biologics. Our facility for assembly, labeling and packaging manufactures advanced delivery systems and ensures required labeling and secure packaging of the therapies for patients worldwide.

The Hillerød campus also houses quality control laboratories, warehouses, and a number of organizations, supporting the manufacturing activities: planning and purchasing, engineering, and quality assurance.

Qualifications and Education

We are an equal opportunity and affirmative action employer.  All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state or local law.   

Employment Category

Full time Regular

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