Cpl, in partnership with our client Pfizer, are currently recruiting for an Operations Support Specialist to work in their state-of-the-art Biologics facility in Grange Castle, Dublin West.
Operations Support Team of Specialists in Grange Castle are system and operational process subject matter experts (SME’s). The Operations Support Specialist balances the requirements of day to day support, implementation of system/operational process continuous improvements (CI) and corrective actions, preventive actions (CAPA’s).
The ideal candidate will be self-driven and will be recognized as having a high level of knowledge/skill.
Project management, tracking, monitoring, and implementing initiatives to improve efficiency will be a key requirement.
This role will support the implementation of Manufacturing Execution System (MES) for Electronic Batch Records (EBR’s). in DS proteins and requires a technical understanding of the manufacturing process to facilitate design of EBRs for same. The ideal candidate should have experience in executing projects in line with lean / six sigma tool and techniques.
- Support the implementation of AMPS in DS proteins.
- Process flow mapping.
- Gap Analysis of systems.
- Authoring and Approval of SOP's, Forms, Protocols, Electronic Batch Records, Training content & other documents for operations through collaboration with the various departmental SME’s.
- Providing subject matter expertise and support for business systems and processes, technologies and products for manufacturing process.
- Demonstrating company values and Pfizer competencies.
- Working to implement a culture of Zero Defects through partnerships with Manufacturing Operations.
- Providing leadership in the use of OE and Lean principles to optimise our technical and business processes.
- Reporting/managing of project metrics.
- Assisting with creation & closure of Quality system change controls.
- Carry out organisational activities such as co-coordinating communication information.
Third level Qualification in Science, Engineering or equivalent is preferred, though not essential. Exceptions may be considered where relevant skills/experience and correct attitude and behaviors exist (this may be supplemented by further education in parallel).
1-3 years’ experience working in cGMP manufacturing environment is essential. A track record of achievement and delivering successfully in a team environment is required.
The following would be considered an advantage:
- Working knowledge of Downstream Operations, Buffer/Media Makeups and General Support Equipment for Bio Processing.
- Previous experience with an electronic document management system (eBRs, PMX).
- PDOCS experience.
- Familiarity with Change control, Investigation and Documentation Processes in a manufacturing environment.
- An ability to work independently, and as a member of a global team in a dynamic, fast-paced environment that requires flexibility and initiative.
- Experience in a biopharmaceutical or pharmaceutical cGMP manufacturing or regulated environment or equivalent is preferred.
- Excellent communication skills including computer literacy and ability to work independently and in teams.
- An ability to deal with process change and implement new effective processes.