J&J Family of Companies Senior Manufacturing Process Specialist (IPT Team) in Ringaskiddy, Ireland
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at https://www.jnj.com
Job Function: Supply Chain Manufacturing
Job Sub Function: Manufacturing Process Improvement
Job Category: Professional
Job Description:
About Innovative Medicine
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine
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:
1. Management of In Process Testing equipment across all manufacturing suites.
2. Managing IPT equipment uptime and troubleshooting reliability issues.
3. Coordinating vendor PM and calibration of IPT equipment.
4. Representing Operations on cross-functional project implementation teams.
5. Monitoring and troubleshooting of the manufacturing process and equipment issues and process optimization.
6. Monitoring and reporting of process performance using statistical process control.
7. Troubleshooting of DCS (e.g. Delta V) and PLC control systems.
8. Preparation and updating of Batch Records, Procedures, and Work Instructions.
9. Providing process and equipment-related training as required within the Manufacturing Department.
10. Completion of assigned tasks to support the manufacture of quality biomedicines in accordance with cGMP and EHS requirements.
General Scope of Responsibilities:
1. 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.
2. Carry out routine and non-routine tasks delegated by the Operations Manager according to appropriate procedures, values, and standards.
3. Carry out all activities in compliance with corporate and cGMP/EHS regulatory requirements.
4. Compliance with Manufacturing and general site procedures at all times and completion of all documentation in compliance with site procedures and GDP.
5. Lead, support and participate in commissioning and qualification activities both current and future projects (and annual re-qualification activities). Also support validation activities.
6. Lead and support investigation and resolution of problems on plant and participate in and lead Cross-Functional teams as necessary.
7. Generate and assist with generation, review, and revision of Manufacturing documentation as necessary.
8. Ensure that personal training requirements are completed in compliance with site procedures. Training and support for new recruits to the Manufacturing group.
9. Support ongoing studies by Validation, OTS, and other support functions.
Leadership Responsibilities / Individual Contribution:
1. Be familiar with daily activities in manufacturing.
2. Facilitate an environment of continuous improvement and open communication.
3. Lead investigations in work area as necessary.
4. Collaboration and teamwork.
5. Initiative and motivation.
6. Share ideas and suggestions for improvement and encourage others to do the same.
7. Interface with all site departments, Operations, and Maintenance.
8. Contact with Engineering, Quality, Logistics, OTS, Validation, and Training departments. Contact with other Janssen Biologics sites.
9. Be conscious of internal customers to the Manufacturing department and be cognizant of their requirements.
Qualifications / Requirements:
1. Minimum bachelor’s degree in either Microbiology, Biochemistry, Pharmacy, Biotechnology, Science, or Engineering.
2. Manufacturing experience within a GMP regulated environment.
3. Experience of the cell culture or purification processes.
4. Process engineering experience.
5. Commissioning and qualification experience.
6. Experience of Microsoft Word, Excel, and Outlook.
7. Experience of DCS (e.g. Delta V), SCADA, and PLC systems.
8. Experience of SAP, LIM’s and/or other business systems.
9. 6-Sigma/Kepner-Tregoe or similar problem-solving/decision-making methodology training.
10. 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:
1. Take reasonable care to protect his or her own and the safety of their colleagues who may be affected by their actions.
2. Comply with EHS rules and procedures at all times.
3. Understand the potential EHS impact of their activities.
4. Attend and participate in EHS training as required.
5. Use PPE and safety equipment as required.
6. Report all incidents, accidents, and near miss events.
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