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.

Responsibilities: 

• 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.

Leadership responsibilities:

• 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

Desirable:

• 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.

Key Competencies:

• Excellent interpersonal skills.
• Ability to operate as part of a team is critical.
• Customer focus.
• Innovative.
• Mechanical/Technical aptitude.
• Excellent communication skills both written and verbal.
• Attention to detail
• Good problem-solving skills.
• Results and performance-driven.
• Adaptable and flexible.