The Sterile Manufacturing Team Member is responsible for operating process and filling equipment within a clean room manufacturing facility. An essential part of this role is ensuring the operation works to the highest safety and GMP standards. The role also plays a significant role in ensuring all batch related documentation meets the standards expected for a sterile manufacturing facility.
Essential Duties, Functions and Responsibilities:
- Prepare the manufacturing equipment and facility for production batches
- Manufacture finished product to GMP standards
- Carry out all operations in the assigned area in accordance with Standard Operating Procedures (SOPs) and as directed by the relevant Manufacturing Batch Records (MBRs)
- Is trained and qualified to work in a grade B cleanroom and maintains this qualification
- Knowledge of aseptic manufacturing techniques and procedures
- Capable of working with equipment automation systems required to operate those systems
- Excellent communication skills.
- Minimum of leaving certificate level education
- Certificate or Diploma in a GMP or technical subject would be a distinct advantage
- At least 4-6 years’ experience working in a fast paced regulated GMP packaging environment.
- Familiar with GMP manufacturing
- Experience of inputting to and updating SOPs and Work Instructions
- Ideally 1-2 years working as a sterile manufacturing operator
Work Environment/Hazards and Physical Demands:
There is a high physical demand in this role due to the nature of working for extended periods of time in a grade B cleanroom.
Hours of Work
The successful candidate will be required to work in the shift pattern determined by the site - currently a two cycle rotating shift cycle
For more information, please contact Jenny Navan on 016146072 or via email Jenny.Navan@cpl.ie