Manufacturing Process Engineer
2 weeks ago
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, LIMâs and/or other business systems.
⢠6-Sigma/Kepner-Tregoe or similar problem solving/decision making methodology training.
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