Sterile Manufacturing Team Member
Details:
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.
Aerie Pharmaceuticals is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to gender, marital status, family status, age disability, sexual orientation, race, religion or membership of the Traveller community status.