Pharmaceutical & Biotechnology
BioProcess Specialist
- Contract
- Ringaskiddy, County Cork, Ireland
- 42034219
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, LIM’s 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 niamh.mcdonald@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***
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, LIM’s 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 niamh.mcdonald@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***
Similar Jobs
Pharmaceutical & Biotechnology
Quality Systems Specialist
- Contract
- County Carlow , Carlow , Ireland
Similar Jobs
Pharmaceutical & Biotechnology
Project Engineer
- Contract
- North Dublin , County Dublin , Ireland
Similar Jobs
Pharmaceutical & Biotechnology
Site Remediation Lead
- Contract
- County Dublin , Dublin City Centre , Ireland
Similar Jobs
Pharmaceutical & Biotechnology
Senior Science Associate
- Contract
- County Dublin , Dún Laoghaire , Ireland
Similar Jobs
Pharmaceutical & Biotechnology
Senior QA Specialist
- Contract
- County Dublin , North Dublin , Ireland