PROCESS OPERATOR – STERILE OPERATIONS

We have an opportunity for a Process Operator to join our Sterile Operations team. This role is responsible for the operational activities within EirGen Pharma, for providing support to the project team and for ensuring maximum production quality, while supporting the policies, goals and objectives of the company.

Responsibilities of this role include:

Health, Safety and the Environment

  1. Comply at all times with the Health, Safety and Environmental policy and associated procedures.
  2. Continuously promote a positive safety culture by challenging yourself and others to prioritize safety in everything you do.

Quality Compliance

  1. Ensure all work carried out, is in compliance with the required standards, conforming to company, cGMP, SOP’s and regulatory guidelines.
  2. Take ownership for quality compliance in all activities you are responsible for.

Manufacturing Operations

  1. To assist in the development of new SOPs/WIs as author and SME for production equipment and procedures.
  2. To work with Operations team to maintain project schedule adherence through operational readiness preparation.
  3. To manufacture and inspect Media Fill batches and subsequent GMP batches
  4. Identify and make recommendations for improvements as part of a team within or outside the department in order to ensure continuous improvement.
  5. Support Project delivery as needed through procedure development, FAT, SAT and validation of process equipment.
  6. Proactively contribute in production incident investigations and problem solving sessions.
  7. Actively participate in Tiered accountability meetings.
  8. Communicate directly with the maintenance personnel to coordinate maintenance and repair work in manufacturing areas.
  9. Perform preventative maintenance activities as required.
  10. Assists maintenance technicians in performing maintenance and repairs.
  11. Assists with diagnosing and trouble-shooting maintenance related issues.

The ideal candidate for this role will meet the following criteria:

  1. Minimum 1 years’ experience within the pharma or biopharma sector.
  2. Experience in working in a Sterile Manufacturing environment is essential as well as hands on experience in aseptic operations.
  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.

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