Process Operator - Fill Finish Manufactu
Process Operator – Fill Finish Manufacturing. Key Purpose: Our client is looking to recruit a Process Operator who will be responsible for the operational activities and act as support to the project team. The ideal will ensure maximum production quality, while supporting the policies, goals and objectives of the company. The ideal candidate will have excellent Communication skills, both verbal & written a previous working knowledge of Sterile Manufacturing and a good understanding of aseptic behaviors. This role reports directly to the Operations Team Lead. Key Responsibilities: 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. Qualifications & Experience: Minimum 1 years’ experience within the pharma or biopharma sector. Sterile Manufacturing experience an advantage. Experience in Fill Line Operations, Formulation or Vial Inspection an advantage. Working on a project team an advantage. Working in a start-up facility an advantage. This job originally appeared on RecruitIreland.com.
6 days ago