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Manufacturing Science Process Engineer

Location
Dublin, County Dublin
Salary
€66.00 to €71.00 Per Hour
Job Type
Contract
Posted
8 Sep 2022
Manufacturing Science Process Validation Engineer Role: Process Validation activities for existing/new products designated for the biologics manufacturing facility. Actively coordinates all process validation and process simulation activities with the biologics manufacturing facility. Act a Subject Matter Expert (SME) for Process Validation in compliance with GMP and regulatory requirements. Responsibilities: As part of Op Readiness:Coordinate all APS and PV activities within the scope of regenerative medicine manufacturing Advocate team problem solving. Working proactively to positively affect metrics, morale and metrics such as schedule adherence and quality attributes Supports delivery the Tech Transfer and Production Schedule Liaise with QC, QA, Development Scientists, CQV, Training, CAPEX, Logistics, Supply Chain and Manufacturing to ensure adherence to schedule and efficient troubleshooting Lead regulatory requirements associated with Process Validation and communicate them to project and ops team. Shared ownership of planning, implementation, and evaluation of experimental programs with regard to the validation of manufacturing process incl. design of experiment, continuous process verification and process capability evaluation. Integration and alignment with P3 operations team with achieving overall operational readiness schedule adherence. Actively participate in problem identification, problem solving and change initiatives in cooperation with other teams and services. Continuous improvement with a cross functional focus is a core activity. Drive development, transfer and validation of process optimization initiatives in an aseptic manufacturing environment. Actively generate required documentation and change controls relating to process validation activities in an accurate and timely manner. Such documentation to include Process Validation protocols, BMR Reviews and SOPs. As part of production operations: Manufacturing and process subject matter expert with regard to validation of aseptic manufacturing, bioprocessing and regenerative medicines; Participate in and support regulatory audits Maintain and implement quality standards to cGMP guidelines supporting and leading investigations in validation, manufacturing and technical deviations. Ensure validations are in place in process validation, cleaning validation, aseptic validation Execute, lead and participate in risk assessments associated with validation of the manufacturing process Liaise with QC, QA, Development Scientists, CQV, CAPEX, Logistics, Supply Chain and Manufacturing to ensure adherence to schedule and efficient troubleshooting Provide direction to Technical Transfer team to ensure manufacturing facilities are operational ready and in compliance with Quality standards. General Responsibilities: Support a culture of open communication, fairness and transparency. Maintain team training requirements and ensure team members are suitably trained. Contribute to Drive a continuous improvement mind-set in line with AGILE program. Support the implementation of Standard Work amongst team ensuring activities are coordinated and integrated (training, documentation, process improvements, investigation activities etc.) using an inclusive planning system. Uphold Company Code of Conduct. Compliance in accordance with client quality standards, GWPs, cGMPs and all other relevant policies, procedures, regulations and standards including Health & Safety and Environmental (HSE) Legislation. Actively foster, in cooperation with other client staff, an ethos and culture of safety awareness. Ensure that Accident Reports / Near Miss Forms are completed in a timely manner after an event. Ensure timely completion of all SOP, reading, training and assessment. Requirements: Science, Engineering or Biochemistry Degree or other relevant field of expertise. Relevant Experience/Criteria: At least 5 years experience in Pharma Manufacturing including Process Validation and/or technology transfer preferably in the biopharmaceutical / bioprocessing field. Detailed and in-depth knowledge of Biopharmaceutical Manufacturing Operations and Quality and Regulatory Affairs. Detailed knowledge in experimental design, statistical data analysis and quality by design Experience of aseptic GMP manufacturing and filling is considered essential. Manufacturing experience in biopharmaceutical operations involving cell cultures or Regenerative Medicines and VHP decontamination an advantage. Experience in Electronic Quality Management and Document Systems (EQMS, EDMS), Manufacturing Execution Systems (MES) and SAP an advantage Experience in operational excellence Lean/Six Sigma, Green Belt Certification is an advantage
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Details

  • Job Reference: 707467930-2
  • Date Posted: 8 September 2022
  • Recruiter: Asset Recruitment Ltd
    Asset Recruitment Ltd
  • Location: Dublin, County Dublin
  • Salary: €66.00 to €71.00 Per Hour
  • Sector: Engineering
  • Job Type: Contract