We are seeking a skilled Industrial Manufacturing Specialist to join our Fill Finish Manufacturing site in Sligo on a 12-month contract.
About the Role:
The successful candidate will be responsible for providing expert input on equipment commissioning and qualification related to aseptic fill-finish manufacturing, leading the design, onboarding, and qualification of single-use systems, and collaborating with supplier technical teams.
Responsibilities:
* Provide expert input on equipment commissioning and qualification related to aseptic fill-finish manufacturing.
* Lead the design, onboarding, and qualification of single-use systems.
* Collaborate with supplier technical teams to build and maintain strong relationships.
* Serve as the technical representative on site teams, focusing on design updates and the introduction of new single-use systems.
* Create and align process flow diagrams for new product introductions (NPI) and technology transfers.
* Work closely with the NPI Lead to ensure smooth product transfers and implement process improvements.
* Act as the SME for investigations, process improvements, and efficiency monitoring.
* Write gap assessments, facility fit studies, process safety evaluations, and risk assessments for NPIs.
* Prepare scientific reports, technical documentation, and presentations for internal and external stakeholders.
Requirements:
* Third-level degree in Chemical Engineering, Bioprocess Engineering.
* 3-5 years' experience in biopharmaceutical industry.
* Experience with new product introductions/technology transfers in a fill finish manufacturing facility.
* Experience in biologics manufacturing at scale in a fill-finish facility, serving in a technical role.
About You:
To be successful in this role, you will need a strong background in industrial manufacturing, excellent communication skills, and the ability to work effectively in a team environment.
What We Offer:
We offer a competitive salary, comprehensive benefits package, and opportunities for professional growth and development.