Biopharma Process Specialists

Kenny-Whelan (a specialist division of the CPL group) are hiring further Manufacturing Process Specialists to work on contract at Janssen Sciences in Ringaskiddy Cork. NEW vacancies Feb 2025 Not considering entry level or graduates this time BU2 Manufacturing Process Specialists Location: Cork – Ringaskiddy Contact Jenn Dinan on 0214665408 or email jdinan@kenny-whelan.ie MUST ALREADY BE ELIGIBLE TO WORK ON CONTRACT IN THE REPUBLIC OF IRELAND- i.e have a valid work permit with 12 months permission + on it. JOB DESCRIPTION TITLE: Manufacturing Process Specialist Reports to Operations Manager POSITION SUMMARY: Reporting to Operations Manager, this position is responsible for representing operations on capital project teams and supporting first line troubleshooting of the day-to-day activities within Operations. These activities include but are not confined to: General Activities

• Represent Operations on cross functional project implementation teams.
• Monitoring and troubleshooting of the manufacturing process and equipment issues and process optimization.
• Monitoring and reporting of process performance using statistical process control.
• Troubleshooting of DCS (e.g Delta V) and PLC control systems.
• Investigating and resolving issues raised within the Manufacturing Department.
• Participate in/Lead Cross Functional teams when required.
• Support of Commissioning and Qualification activities.
• Preparation and updating of Batch Records, Procedures and Work Instructions.
• Provide process and equipment related training as required within the Manufacturing Department.
• Completion of assigned tasks to support manufacture of quality biomedicines in accordance with cGMP and EHS requirements.

GENERAL SCOPE OF RESPONSIBILITIES:

• Lead by example and strive to perform to high standards at all times.
• Responsible and accountable for assuring the safe accomplishment of job activities, following good environmental practices and procedures. Commit to and demonstrate safe behavior in every activity.
• Carry out routine and non-routine tasks delegated by the Operations Manager according to appropriate procedures, values, and standards.
• Carry out all activities in compliance with corporate and cGMP/EHS regulatory requirements.
• Compliance with Manufacturing and general site procedures at all times.
• Completion of all documentation in compliance with site procedures and GDP.
• Execution of activities as necessary to meet operational and business needs.
• Lead, support and participate in commissioning and qualification activities both current and future projects (and annual re-qualification activities). Also support to validation activities.
• Prioritize and schedule activities to support business needs and to meet requirements of Master Production Schedule.
• Lead and Support investigation and resolution of problems on plant.
• Participate in and lead Cross-Functional teams as necessary.
• Generate and assist with generation, review, and revision of Manufacturing documentation as necessary.
• Ensure that personal training requirements are completed in compliance with site procedures. Training and support for new recruits to the Manufacturing group.
• Support ongoing studies by Validation, OTS and other support functions.

ORGANISATIONAL INTERFACES: Interface at (Team Leader, Manager and Director level) 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 Manufacturing department and be cognizant of their requirements. QUALIFICATIONS AND EXPERIENCE ESSENTIAL:

• A relevant third level qualification in either Microbiology, Biochemistry, Pharmacy, Biotechnology, Science or Engineering.

DESIRABLE:

• 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, LIM’s and/or other business systems.
• 6-Sigma/Kepner-Tregoe or similar problem solving/decision making methodology training.

MUST ALREADY BE ELIGIBLE TO WORK ON CONTRACT IN THE REPUBLIC OF IRELAND- i.e have a valid work permit with 12 months permission + on it. All applications will be treated with the strictest of confidence. Contact Jenn Dinan on 0214665408. #J-18808-Ljbffr