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Technical Services Specialist Lead
1 week ago
We are seeking a highly skilled Technical Services Specialist to support our client's Fill Finish Facility in Dublin, Republic of Ireland.
The successful candidate will be responsible for providing technical expertise to support all aspects of drug product manufacturing. This includes:
- Providing technical support to commissioning, automation, and manufacturing operation teams.
- Serving as a process SME to support technology transfers of new products into the facility.
- Leading troubleshooting efforts and deviation investigations in conjunction with internal partners.
- Assessing single-use systems and authorizing their use based on extractables and leachables data.
- Authoring and reviewing process supporting documentation, including process descriptions, gap assessments, technical protocols, and reports.
- Supporting the introduction of new raw materials and consumables through the generation of materials lists and Bills of Material updates.
- Working closely with Quality, Supply Chain, and Manufacturing Operations teams to ensure availability and release of materials.
- Reviewing change controls for impact on product quality, safety, and efficacy.
- Providing on-floor technical support and troubleshooting.
- Partnering with Operations to support protocol completion, execution, and sample reconciliation.
- Generating documentation reports for technical studies.
To succeed in this role, you will need strong technical skills, excellent communication abilities, and the ability to work effectively in a team environment.
