Process Specialist

PE Global is currently recruiting for a Manufacturing Process Specialist on behalf of our client based in Cork.

Full Time 12 Month Contract

POSITION 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.

GENERAL SCOPE OF 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 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 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.

LEADERSHIP RESPONSIBILITIES / INDIVIDUAL CONTRIBUTION

• Report to Operations Manager.
• Represent Operations on cross functional project teams.
• Be familiar with daily activities in Manufacturing.
• Facilitate an environment of continuous improvement.
• Facilitate an environment of open communication.
• Lead investigations in 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

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

IMPORTANT

This position description is a general guideline for colleagues, it does not purport to be an exhaustive list of all elements of the position. Management reserves the right to modify this position description at any time, or to vary the duties and responsibilities of the position to meet production, scheduling or other business needs.

Interested candidates should submit an updated CV.

Please click the link below to apply, call Audrey on 0214297900 or alternatively send an up-to-date CV to audrey.mccarthy@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***