Manufacturing Process Engineer

3 weeks ago

Cork, Cork, Ireland Cpl Full time

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.

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