Engineering Project Manager
CK Group are recruiting for an Engineering Project Manager to join a company in the Pharmaceutical industry at their site based in Wokingham on a contract basis for 12 months.
Up to £38.70 PAYE or up to £51.99 umbrella
Engineering Project Manager:
- Leading the implementation and execution of process validations including reporting, product life-cycle improvements and technical transfer projects in compliance with internal Janssen/Meira corporate and global regulatory expectations.
- Supporting Technical Transfer activities through generation of protocols/reports, technical writing, execution of laboratory scale studies and participation in manufacturing operations including support on related aseptic process manufacturing activities e.g. sanitization, sterilization and aseptic simulation process development.
- Supporting “process fit to plant” during early and late stages of development to provide guidance to both development and manufacturing teams.
- Partnering with Project Teams to provide input, review and approval support for BLA submissions.
- Participating in cross-functional project teams.
- A minimum of a Bachelor's degree in Biology, Pharmacy, Engineering or related scientific field is required, advanced degree is preferred.
- 8+ years’ experience within a regulated biologics or pharma industry, preferred gene therapy experience.
- Biological commercial manufacturing experience, either cell culture and/or purification and/or fill finish processes and strong process validation knowledge, in gene therapy programs is a plus.
- Good knowledge of EHSS and GMP requirements.
- Capable of planning and leading experiments or projects steps with some supervision.Company: Our client is part of one of the largest Pharmaceutical companies in the world. Their Consumer segment includes a broad range of products used in the baby care, skin care, oral care, wound care and women's health care fields.
Location: This role will be based at our clients site in Wokingham, Berkshire.
Apply: Entitlement to work in the UK is essential. For more information, please contact the Key Accounts Team on 01438 870011 or email firstname.lastname@example.org. Please quote reference 51912.