Job Overview:
This role is a vital part of the manufacturing operation for biologics in Sligo.
It's a 12-month contract position that requires collaboration with cross-functional teams to ensure compliance with safety, regulatory, and organizational requirements.
Responsibilities include:
* Developing and modifying procedures as needed to support the manufacturing operation;
* Participating in process, equipment, and facilities validations efforts and projects implementations;
* Reviewing and approving process-related commissioning, qualification, and validation protocols for completeness and accuracy;
* Executing protocols in a timely basis to meet project schedule requirements;
* Leading Process FMEAs for Visual Inspection and establishing, optimizing processes for certification of technicians;
* Maintaining a defect library and trending Visual Inspection Defects;
* Ensuring alignment of Site Visual Inspection procedures with Global Guidance Documents and Regulatory Requirements;
* Providing technical input to guide SOP development for Visual Inspection;
* Leadership of manufacturing and validation activities during project life cycle;
* Coordination with internal/external stakeholders for particle/defect evaluation;
* Investigating process exceptions or malfunction incidents affecting the process.
Requirements:
* Relevant third-level qualification in an engineering, science, or technical discipline (Degree Level or Master's Preferable);
* At least three (3) years of combined experience in Technical/Operations/Quality or equivalent in a Pharmaceutical and Health Care Organization;
* Experience in the manufacturing environment of a biotechnology, pharmaceutical, or health care plant, preferably with knowledge of clean utilities.
A strong understanding of manufacturing processes, including those for biotechnological drugs, parenteral drugs, solutions preparation, fill finish, Lyophilisation, sterilization operations is desirable.
The ideal candidate will have a proven track record of delivering results in a fast-paced environment and be able to work collaboratively with cross-functional teams.