Do you have Cleaning Validation experience? Are you looking for a contract role based in an ongoing Dublin based Biopharmaceutical facility? If so, this is the role for you.
The Cleaning Validation Technical Specialist will support the cleaning validation activities for the cGMP manufacture of biological bulk drug substance (BDS) at the client's facility in Dublin. The Specialist will provide cleaning validation expertise to support the facility design, start-up and routine commercial manufacturing. The Cleaning Validation Technical Specialist will be responsible for validation and verification of the cleaning used to support the technology transfer of new or existing drug substance manufacturing processes to the facility, and will be required to work in close collaboration with Process Development, Engineering, Supply Chain, Quality, Regulatory, Comissioning and other involved departments to ensure successful facility design, construction, startup and qualification. The position is accountable for timely completion of cleaning validation/verification related milestones, with particular emphasis on cleaning validation for a multi-product drug substance manufacturing facility.
The Cleaning Validation Technical Specialist will need:
- Minimum requirement B.Sc. in Biochemistry, Biology, Chemistry or equivalent, or B.Eng. Process or Chemical Engineering.
- Minimum 5 years' experience in Technical Services / Manufacturing / Technical Development/Quality Support in a biological bulk drug substance manufacturing organization in a Cleaning validation capacity.
- Technical and operational knowledge of Cleaning validation/verification, quality systems and regulatory requirements across multiple health authorities.
- Experience of cleaning validation is a must, and/or cleaning approaches to multiproduct is advantageous.
- Comprehensive understanding of cGMP requirements for biopharmaceutical manufacturing.
- Good interpersonal skills coupled with demonstrated ability to effectively work in a matrix organization.
- Ability to present and successfully defend technical and scientific approaches in both written and verbal form.
- Ability to drive for results independently and adapt to rapidly changing priorities
For more information on this role please contact Eoin
or apply direct through this advert.