Job Title: Technical Specialist
About the Role
We are seeking a highly skilled Technical Specialist to support our client's operations in Cork. This is a full-time 12-month contract position.
Key Responsibilities
* Participate actively in the microbiological control and assurance program within the operations department.
* Manage activities in compliance with corporate, cGMP, EHS, and other regulatory requirements.
* Lead by example and strive for high standards at all times in compliance with Credo and Standards of Leadership.
* Perform routine area walkdowns/GEMBAs and support process microbiological investigations.
* Define specific aseptic techniques for crucial process steps and support periodic review of environmental monitoring trends.
Requirements
* BSc in a scientific/technical discipline (ideally microbiology).
* Minimum 5 years' experience in a pharmaceutical or GMP-regulated Operations environment.
* Possess knowledge and experience of shop floor manufacturing processes.
* Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.
Desirable Qualifications
* Validation experience in a Life Sciences or Biopharmaceutical manufacturing environment.
* Business Excellence and Problem Solving skills.
* Advanced degree (MS, MBA, PhD).