The Sterile Manufacturing Team Member works as part of the Manufacturing Team preparing and 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 Good Manufacturing Practices (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:
- Prepares the manufacturing equipment and facility for production batches.
- Manufactures finished product to cGMP standards.
- Is trained to and follows the manufacturing procedures and systems of work designed to ensure the facility meets its safety, quality, delivery and cost goals
- Is trained and qualified to work in a grade B cleanroom and maintains this qualification.
- Participates in bi-annual media fill studies to maintain qualification status.
- Is diligent in the completion and review of batch and related documentation required to support the manufacturing process.
- Is disciplined in ensuring personal hygiene at all time, and in following the garbing and hygiene expectations of working in a sterile manufacturing environment.
- Assists the Quality organisation in In Process Checks and sampling of product and environmental conditions.
- Follows procedure in the movement of materials in and out of the cleanrooms.
- Participates in continuous improvement teams and develops improvement ideas.
- Supports investigations into manufacturing deviations.
- Takes responsibility for manufacturing equipment and area condition and supports maintenance activity in the manufacturing area.
- Supports capital projects throughout equipment lifecycle.
- Supports product or process development projects and associated validation activities.
- Is always prepared to escalate any safety or quality risk observed.
- Knowledge of aseptic manufacturing techniques and procedures.
- Capable of working with equipment automation systems required to operate those systems.
Educated to Leaving Certificate Level.
Certificate or Diploma Qualification in a GMP or technical subject would be a distinct advantage.
- At least 4 – 6 years’ experience in a high volume manufacturing environment in Pharmaceuticals, Medical Device or other equivalent industries.
- Ideally 1-2 years working as a sterile manufacturing operator.
For more information please call me on 087 9728431 or send me your CV to firstname.lastname@example.org
To apply for this job email your details to email@example.com