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We are searching for the best talent for the Manufacturing Process Specialist role to be in Cork, Ireland.

Purpose:

The manufacturing process specialist will be responsible for representing operations on capital project teams and supporting first line troubleshooting of the day-to-day activities within operations.

You will be responsible for:

• Representing 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

• Participateing in/ Leading Cross Functional teams when required.

• Supporting of Commissioning and Qualification activities

• Preparation and updating of Batch Records, Procedures and Work Instructions

• Providing 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.

Leadership Responsibilities / Individual Contribution

• Be familiar with daily activities in manufacturing.

• Facilitate an environment of continuous improvement and open communication.

• Lead investigations in work area as necessary.

• Collaboration and teamwork.

• Initiative and motivation.

• Share ideas and suggestions for improvement and encourage others to do the same.

• 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 Manufacturing department and be cognoscente of their requirements.

Qualifications / Requirements:

• Minimum bachelor’s degree in either 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

Desirable:

• Commissioning and qualification experience

• 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.

• Ability to operate as part of a team with attention to detail.

Significant Environmental, Health and Safety Considerations

All employees are required to comply with the requirements of the company’s Environmental, Health & Safety Policy, Safety Statement, associated EHS Procedures, local legislation and duties outlined in the site EHS Manual.

In line with the Safety Health & Welfare at Work Act (2005), all employees are required to:

• Take reasonable care to protect his or her own and the safety of their colleagues who may be affected by their actions.

• Comply with EHS rules and procedures at all times.

• Understand the potential EHS impact of their activities.

• Attend and participate in EHS training as required.

• Use PPE and safety equipment as required.

• Report all incidents, accidents, and near miss events.

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