Manufacturing Process Specialist Job In Cork

Job Description

Join the Upstream Team at Janssen Sciences in Ringaskiddy as a Manufacturing Process Specialist, working on contract and responsible for representing operations on capital project teams.

**Key Responsibilities:** • Represent operations on cross-functional project implementation teams • Monitor and troubleshoot manufacturing process and equipment issues • Optimize process performance using statistical process control • Troubleshoot DCS and PLC control systems • Investigate and resolve issues raised within the Manufacturing Department • Participate in and lead Cross-Functional teams as necessary **Additional Responsibilities:** • Support commissioning and qualification activities • Prepare and update batch records, procedures, and work instructions • Provide process and equipment-related training as required • Complete assigned tasks to support manufacture of quality biomedicines in accordance with cGMP and EHS requirements **Leadership Responsibilities:** • Report to Operations Manager • Represent Operations on cross-functional project teams • Facilitate an environment of continuous improvement • Facilitate an environment of open communication • Lead investigations in the work area as necessary • Lead Cross-Functional teams as necessary to support site goals **Organizational Interfaces:** • Interface with all site departments, Operations and Maintenance • Contact with Engineering, Quality, Logistics, OTS, Validation, and Training departments • Contact with other Janssen Biologics sites • Be conscious of internal customers to the Manufacturing department and their requirements **Qualifications and Experience:** • A relevant third-level qualification in Microbiology, Biochemistry, Pharmacy, Biotechnology, Science, or Engineering • Manufacturing experience within a GMP regulated environment • Experience of the cell culture or purification processes • Project/new equipment installation experience • Process engineering experience • Commissioning and qualification experience • Postgraduate qualification • Experience of Microsoft Word, Excel, and Outlook • Experience of DCS (e.g. Delta V), SCADA, and PLC systems • Experience of SAP, LIMs, and/or other business systems • 6-Sigma/Kepner-Tregoe or similar problem-solving/decision-making methodology training **Key Competencies:** • Excellent interpersonal skills • Ability to operate as part of a team is critical • Customer focus • Innovative • Mechanical/Technical aptitude • Excellent communication skills both written and verbal • Attention to detail • Good problem-solving skills • Results and performance driven • Adaptable and flexible