Manufacturing professionals required for a challenging opportunity in a Pharmaceutical organisation based in Ireland.
This role will be responsible for overseeing all procedures and processes associated with the manufacture of Commercial Large-Scale Drug Substance at a state-of-the-art manufacturing facility. The successful candidate will be responsible for preparing, operating and monitoring equipment, using business systems and carrying out tasks including but not limited to cleaning, validation, in-process testing and basic maintenance of equipment in accordance with current Good Manufacturing Practices (cGMPs).
Responsibilities:
1. Collaborate with the manufacturing operations group, project design team, CQV team and Automation/CSV representatives to develop and validate the manufacturing facility.
2. Support Equipment Design/Hazard Review and Room Programming reviews.
3. Assist the Operations team to consistently deliver on specific area Key Performance Indicators (KPIs), such as EHS metrics, Production Plan, OEE, compliance and team training.
4. Execute commercial manufacturing processes according to established work instructions and Standard Operating Procedures.
5. Generate SOPS/Electronic Batch Records.
6. Adhere to Right First-Time principles.
Requirements:
7. Experience in a GMP Manufacturing environment is essential.
8. Level 7 qualification in a science or engineering discipline is required.
9. Understanding of Drug Substance Manufacturing Operations is desirable.