Manufacturing Process Specialist

Johnson Johnson; Cork; On-site; EUR 78,000 - 105,000; Full time

Job summary

Johnson & Johnson Innovative Medicine in Cork, Ireland, seeks a Manufacturing Process Specialist to optimise biomanufacturing processes and support IPT equipment across manufacturing suites. The role involves first-line troubleshooting, cGMP compliance, and collaboration with cross-functional teams on capital projects.

The candidate will lead commissioning/qualification activities, maintain documentation, and mentor new recruits within a dynamic manufacturing environment.

Qualifications

• Bachelor’s degree in a relevant science or engineering field.
• GMP-regulated manufacturing experience.
• Experience with cell culture or purification processes.
• Process engineering experience.
• Commissioning/qualification experience is desirable.
• Proficiency with MS Office and SCADA/DCS systems is desirable.
• Experience with SAP/LIMS is desirable.
• Six Sigma or similar problem-solving training is desirable.
• Teamwork and attention to detail are essential.

Responsibilities

• Manage IPT equipment uptime and troubleshoot reliability issues.
• Coordinate vendor PM and calibration of IPT equipment.
• Represent Operations on cross-functional project teams.
• Monitor and optimize process performance using SPC.
• Troubleshoot DCS (DeltaV), SCADA, and PLC systems.
• Prepare and update Batch Records, Procedures, and Work Instructions.
• Provide process/equipment training within Manufacturing.
• Support cGMP/EHS compliant manufacturing and documentation.
• Lead commissioning/qualification activities and support validation.

Skills

Manufacturing

GMP knowledge

Cell culture experience

Process engineering

Teamwork

Attention to detail

Problem solving

Education

Bachelor’s degree in Microbiology / Biochemistry / Pharmacy / Biotechnology / Science / Engineering

Tools

DCS (DeltaV)

SCADA

PLC systems

SAP

LIMS

MS Word/Excel/Outlook

Job description

Manufacturing Process Specialist - IPT team

Duration: 12 months

Hours: 39 hours per week

Imagine your next project representing operations on capital project teams, optimising biomanufacturing processes, and managing critical in-process testing equipment at a global leader in innovative medicine.

Johnson & Johnson Innovative Medicine is currently seeking a Manufacturing Process Specialist to join our operations team located in Cork, Ireland.

Are you proficient in ensuring all manufacturing processes comply with industry regulations and standards? Can you develop and manage a preventative maintenance schedule for all production equipment? Looking for a role where your attention to detail and skills make a difference? Then we have a position for you!

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.

roles and responsibilities

• Management of In Process Testing (IPT) equipment across all manufacturing suites.
• Manage IPT equipment uptime and troubleshoot reliability issues.
• Coordinate vendor PM and calibration of IPT equipment.
• 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.
• 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.
• 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 and completion of all documentation in compliance with site procedures and GDP.
• Lead, support, and participate in commissioning and qualification activities for both current and future projects (and annual re-qualification activities), as well as providing support to validation activities.
• Lead and support investigation and resolution of problems on plant and 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.
• Be familiar with daily activities in manufacturing.
• Facilitate an environment of continuous improvement and open communication.
• Lead investigations in the 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 in the Manufacturing department and be cognizant of their requirements.
• 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): take reasonable care to protect their 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.

how to succeed

• 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.
• Process engineering experience.
• Commissioning and qualification experience (Desirable).
• Experience of Microsoft Word, Excel, and Outlook (Desirable).
• Experience of DCS (e.g., Delta V), SCADA, and PLC systems (Desirable).
• Experience of SAP, LIMS, and/or other business systems (Desirable).
• 6-Sigma/Kepner-Tregoe or similar problem solving/decision making methodology training (Desirable).
• Ability to operate as part of a team with attention to detail (Desirable).

This role offers a very competitive hourly rate. This contract will run for 12 months

you are welcome here

Johnson & Johnson is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

about Johnson & Johnson Innovative Medicine

Patients inform and inspire our science-based innovations, which continue to change and save lives. Applying rigorous science and compassion, we confidently address some of the most complex diseases of our time and unlock the potential medicines of tomorrow.

Our diverse portfolio spans multiple therapeutic areas — Oncology, Immunology, Neuroscience, Cardiovascular, Pulmonary Hypertension, and Retina.

We are continuously working to develop treatments, aspiring to find cures, pioneering the path from lab to life, and championing patients every step of the way.

Diversity, Equity & Inclusion

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.