Manufacturing Process Specialist

Johnson & Johnson Worksense (via Randstad Sourceright) is responsible for finding, engaging and contracting talent for the Johnson & Johnson contingent workforce.

We are currently recruiting a Manufacturing Process Specialist to join our contingent workforce on a growing team in Janssen Pharmaceuticals in Cork for an initial 12 months month contract. 

About Janssen Pharmaceuticals:

Janssen Sciences Ireland UC, (previously Janssen Biologics), is part of the Johnson & Johnson family of companies, the world’s most comprehensive and broadly-based manufacturer of healthcare products and related services.  Our site in Ringaskiddy was established in 2005 on a 100-acre site with an investment of €500 million. We manufacture a range of biopharmaceutical products indicated for the treatment of conditions that include rheumatoid arthritis, psoriasis and cancer.  

We are expanding our site to allow us to meet the critical needs of patients around the world.  The expansion plans involve an investment of more than €300 million that will increase the existing manufacturing space by an additional 19,100m2, provide employment for up to 450 people during construction and an extra 200 people once completed.

About the role: 

Reporting to Operations Manager, this position is responsible for representation operations on capital project teams and supporting first line trouble-shooting of the day to day activities within Operations

Key Responsibilities:

• 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.
• 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.

Candidate Requirements:

• A minimum of a Bachelor's degree Chemistry, Biochemistry or related Scientific discipline.
• At least 2 years of experience in a similar role. 
• Experience of the cell culture or purification processes
• Project / New equipment installation 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.

If you meet our requirements and are interested in hearing more about our Manufacturing Process Specialist role, please do not hesitate to apply through the provided link today and a member of our recruitment team will be in touch!