Job Summary
We are seeking a Technical Services Specialist to provide technical expertise to support drug product manufacturing at a client Fill Finish Facility.
* Provide significant technical expertise to support all aspects of the drug product manufacturing.
* Process SME to support commissioning, automation and manufacturing operation teams.
* Support technology transfers of new products into the client Facility.
* Lead troubleshooting efforts and deviation investigations in conjunction with internal partners.
* SME for introduction of single use systems and assessment of their use in terms of extractables, leachables.
Key Responsibilities
* Author and review process supporting documentation.
* Review process descriptions, gap assessments, technical protocols and reports.
* Generate materials lists, Bills of Material updates, material specifications.
* Partner with colleagues in Quality, Supply Chain and Manufacturing Operations.
* Technical review of change controls for impact to product quality, safety and efficacy.
* Provide on-floor technical support and troubleshooting.
The ideal candidate will have excellent technical skills, strong analytical and problem-solving abilities, and excellent communication and collaboration skills. They must be able to work effectively in a fast-paced environment and prioritize multiple tasks and responsibilities.