Johnson & Johnson
IRL - Manufacturing Process Specialist
Reporting to Operations Manager, this position is responsible for first line trouble-shooting of the day to day activities within Operations.
- Monitoring and troubleshooting of the manufacturing process and equipment issues and process optimization
- Monitoring and reporting of process performance using statistical process control
- Generation of data and reports to support Annual Product Reviews and Regulatory submissions
- Troubleshooting of DCS (e.g Delta V) and PLC control systems
- Investigating and resolving Deviations 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.
- Working assigned shift patterns to meet business needs and manufacturing schedule.
- Lead by example and strive to perform to high standards at all times
- Responsible and accountable for ensuring 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 requalification activities). Also support 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 the 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.
- Report to Operations Manager.
- Be familiar with daily activities in Manufacturing
- Facilitate an environment of continuous improvement
- Facilitate an environment of open communication
- Lead investigations in the work area as necessary.
- Lead Cross-Functional teams as necessary to support site goals.
- Support training of other Manufacturing colleagues.
- Collaboration and teamwork.
- Initiative and motivation.
- Share ideas and suggestions for improvement and encourage others to do the same.
- Demonstrate Credo value of integrity
Qualifications and Experience:
- A relevant third level qualification in either Microbiology, Biochemistry, Pharmacy, Biotechnology, Science or Engineering
- Postgraduate Qualification.
- Manufacturing experience within a GMP regulated environment.
- Experience of Buffer or Media preparation or Equipment preparation in a manufacturing environment.
- Experience of the cell culture or purification processes in either a manufacturing or a lab based environment.
- 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.
- Excellent interpersonal skills.
- Ability to operate as part of a team is critical.
- Customer focus.
- Mechanical/Technical aptitude.
- Excellent communication skills both written and verbal.
- Attention to detail
- Good problem-solving skills.
- Results and performance-driven.
- Adaptable and flexible.