Clinical Biochemistry jobs

Manufacturing Process Specialist

Location: Cork

Duration: 12 months

Hours: 39 hours

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

Roles and 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.

• Serve as a Product Owner for translating the clinical product into a robust, manufacturable process.

• Provide detailed inputs to the Process Capability Assessment and act on its findings.

• Review new product requirements and update or optimize the manufacturing process to meet them.

• Lead/ support Tech Transfer activities.

• Ensure process readiness: equipment, documentation, SOPs/batch records, materials, and validations are complete and approved.

• Execute pilot/wet runs to completion and confirm the process meets release criteria.

• Monitor process trends and performance metrics (yield, cycle time, ); analyze data and identify root causes.

• Deliver clear, actionable feedback to Development, Quality, and Engineering; drive CAPAs and process improvements as needed.

• Manage change control and maintain regulatory and quality compliance throughout NPI activities.

How to Succeed

ESSENTIAL:

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

DESIRABLE:

• 3 + years 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.
  

Benefits

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

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.

Janssen UK: https://www.janssen.com/uk/

Janssen Ireland: https://www.janssen.com/ireland/

Application Process

We are looking to process the first round of applications within the next 2 working days.

We do not accept applications via email. The pay rate for this role will depend on how you are paid. PAYE, LTD & Umbrella options are available.

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”.