Team Member X 2 Sterile

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.

Skills/Knowledge Required:

• Knowledge of aseptic manufacturing techniques and procedures.
• Capable of working with equipment automation systems required to operate those systems.

Education Required:

Educated to Leaving Certificate Level.

Certificate or Diploma Qualification in a GMP or technical subject would be a distinct advantage.

 Experience Required:

• 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 annemarie@amfconsulting.ie