Telephone: 086 4667360
Senior Analyst Engineer
Our Client a Manufacturing Company in Mayo are looking to recruit a Senior Analyst Manager for a 24 month project. Senior Analyst of Manufacturing to support Biologics Capacity Expansion. Work closely with a cross functional team including but not limited to Global Pharm Tech, Engineering, Quality, Validations and external Design Team to develop and qualify commercial manufacturing areas to support the Business needs. Initially the role will be heavily involved in the development and qualification of Biologics vial and prefilled syringe processes to ensure the facilities are commercial ready from a Personnel, Quality, Safety and Opex perspectives.
KEY DUTIES AND RESPONSIBILITIES:
Key duties and responsibilities:
- Develop themselves to become SMEs on biological facility design, aseptics, manufacturing components, primary container closure system, formulations, filling equipment, automation, data integrity, EBR, QRM (CQA’s, CPP’s, CCP’s), cross contamination control, medias strategies.
- Knowledge on all upstream & downstream processes and impact of subprocesses to CQAs, industry complaints, customer, etc…
- High level of input into DFMEA & PFMEAs for facility, equipment and process
- Challenge of Design documentation to meet QA, OPEX and EHS requirements (URS, ES, DS, SDS, HDS, FSDS, RTM, DQ, Pre-FAT, FAT, SAT). Vendor site visits.
- Review, approval & execution of validation activity to meet QA, OPEX and EHS requirements (IQ/OQ/PQ/PPQ)
- Work in conjunction with BCE Trainer on the development of overarching training strategy and roadmap for BCE Operations (Manufacturing)
- Development of process flows, SOPs, risk assessments, training processes, batch records, logbooks and necessary documentation to support a commercial manufacturing department
- Ensuring department is ready for commercial launch from a Personnel, Quality, Safety and Opex perspectives
JOB QUALIFICATIONS (MINIMUM REQUIREMENTS):
- Bachelor’s degree in Science/Engineering or equivalent.
- Minimum 3 years’ experience in the Pharmaceutical/Biopharmaceutical industry
- Minimum 3 years Knowledge/Experience of working within a clean room manufacturing department
- In depth knowledge/experience in Operations requirements for compounding processes, autoclaves, filling machines, deyprogentation tunnels, lyophilization, capping and FMS.
- Good interpersonal and communication skills essential for working across multi-functional teams.
- Competent on all Microsoft desktop packages word, excel, powerpoint
For further information on this Senior Analyst Engineer role in Mayo please contact Anna on 086 4667369 / email@example.com
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