Summary
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 -
These activities include but are not confined to:
General Activities
• 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.
Responsibilities
• 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 behaviour 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.
Qualifications & Experience
Essential
• A relevant third level qualification in either Microbiology, Biochemistry, Pharmacy,
Biotechnology, Science or Engineering
Desirable
• 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.
• 6-Sigma/Kepner-Tregoe or similar problem solving/decision making methodology training.
