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Director of Engineering Manufacturing

vor 2 Wochen


Berlin, Deutschland Hobson Prior Vollzeit

Hobson Prior are currently seeking for a Director of Engineering Manufacturing to join a fantastic establishment on a permanent basis located on either Dusseldorf, Munich, Hamburg or Berlin. For more information, please get in touch now

Please note that to be considered for this role you must have the right to work in this location.

**Key Responsibilities**:

- For this role, you will guide various full-time construction and project engineers, outside service suppliers in implementation of all needed engineering projects.
- To assist in the completion of operational plans within budget, you will control and supervise all costs, capacity planning and utilisation.
- Conduct investigations and develop practical solutions, either independently or with assistance from a small team.
- You will own the engineering program in assistance of the following fields: manufacturing facilities, manufacturing, analytical testing and quality control testing.
- Offer guidance to engineering projects such as construction, equipment, process, continuous improvement actions to guarantee compliance with validations and quality standards.
- Evolve site engineering approaches for clinical manufacturing in compliance with guidelines, regulations and business standards.
- Any other assigned duties.

**Requirements**:

- Educated to a degree level in an engineering discipline.
- At least 10+ years of experience in engineering.
- At least 5+ years of experience in managing a team.
- Know-how of guidelines such as EudraLex, Code of Federal Regulations, as well as industry guidance such as ISPE, PDA, etc.
- Familiarity with equipment and facility design and construction to assist in cGMP biologics manufacturing operations.
- Acquaintance with leadership roles of full-time personnel, outside service suppliers, cooperative internal and external professionals.
- Prior involvement in handling change, problem resolution and inspection promptness.
- Presentation and enablement capabilities.
- Familiarity with biologics based analytical and manufacturing systems.
- Facility design, build, and start-up experience
- Data integrity comprehension and execution.
- Validation implementation.
- Sterile manufacturing acquaintance.
- Past involvement in new modality such as cell and gene therapy.
- Comprehension of product development lifecycle.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.