This role is responsible for the operational activities within EirGen Pharma and as support to the project team. The Process Operator – Fill Finish also ensures maximum production quality, while supporting the policies, goals and objectives of the company.
Responsibilities of this role include:
Health, Safety and the Environment
- Comply at all times with the Health, Safety and Environmental policy and associated procedures.
- Continuously promote a positive safety culture by challenging yourself and others to prioritize safety in everything you do.
- Ensure all work carried out, is in compliance with the required standards, conforming to company, cGMP, SOP’s and regulatory guidelines.
- Take ownership for quality compliance in all activities you are responsible for.
- To assist in the development of new SOPs/WIs as author and SME for production equipment and procedures.
- To work with Operations team to maintain project schedule adherence through operational readiness preparation.
- To manufacture and inspect Media Fill batches and subsequent GMP batches
- Identify and make recommendations for improvements as part of a team within or outside the department in order to ensure continuous improvement.
- Support Project delivery as needed through procedure development, FAT, SAT and validation of process equipment.
- Proactively contribute in production incident investigations and problem solving sessions.
- Actively participate in Tiered accountability meetings.
- Communicate directly with the maintenance personnel to coordinate maintenance and repair work in manufacturing areas.
- Perform preventative maintenance activities as required.
- Assists maintenance technicians in performing maintenance and repairs.
- Assists with diagnosing and trouble-shooting maintenance related issues.
The ideal candidate for this role will have:
|1. Minimum 1 years’ experience within the pharma or biopharma sector.2. Experience in Sterile Manufacturing an advantage but not essential as a full training and development plan will be in place to upskill.|
3. Experience in Fill Line Operations, Formulation or Vial Inspection an advantage.
4. Experience working on a project team an advantage.
5. Experience in a startup facility an advantage.