Technical Operations Specialist
We are currently seeking a highly skilled and experienced Technical Operations Specialist to join our team. This is an excellent opportunity for someone who wants to work in a fast-paced pharmaceutical organization based in Cork.
1. Provide technical support for vaccine drug substance and/or drug product processes, including person-in-plant support within the manufacturing facility.
2. Support Water Runs, Equipment shakedown runs, Engineering Runs, and Process Performance Qualification (PPQ) activities.
3. Collaborate with cross-functional teams to ensure successful support and commercial manufacture of products.
4. Author process change control documentation, technical communications, and process risk management plans.
5. Provide technical oversight, management, and planning support for complex partnership models.
6. Provide guidance to external partners on technology viability, adherence to standards, and deliverable soundness.
7. Lead team assessments of partner risks and develop mitigation plans.
8. Provide manufacturing process support to resolve production issues and optimize process and capacity.
9. Coordinate investigations with other impacted sites and provide technical reviews of process changes.
Requirements:
* A bachelor's degree in engineering or a related science is required; an advanced degree is preferred.
* Experience in pharmaceutical manufacturing, engineering, and technical operations support is essential.
* Excellent leadership, collaboration, change management, interpersonal, analytical, and communication skills are required.
Benefits:
This role offers the opportunity to work in a dynamic environment, collaborate with experts, and contribute to the development of new technologies and processes.