BioProcess Specialist

PE Global Express is currently recruiting for a BioProcess Specialist for a leading multi-national Pharm client based in Cork. This is a 12 month contract position. Role: 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. Requirements: A relevant third level qualification in either Microbiology, Biochemistry, Pharmacy, Biotechnology, Science or Engineering 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, LIMs and/or other business systems 6-Sigma/Kepner-Tregoe or similar problem solving/decision making methodology training Interested candidates should submit an updated CV. Please click the link below to apply, or alternatively send an up to date CV to ***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland*** PE Global Express is currently recruiting for a BioProcess Specialist for a leading multi-national Pharm client based in Cork. This is a 12 month contract position. Role: 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. Requirements: A relevant third level qualification in either Microbiology, Biochemistry, Pharmacy, Biotechnology, Science or Engineering 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, LIMs and/or other business systems 6-Sigma/Kepner-Tregoe or similar problem solving/decision making methodology training Interested candidates should submit an updated CV. Please click the link below to apply, or alternatively send an up to date CV to ***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland*** Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert. Skills: MS Office DCS SCADA PLC systems