Bioprocess Specialist - Cork, Ireland
Rob Walker at CK Science is recruiting for a Bioprocess Specialist to join a leading medical device company based in Cork. This position is initially for the contract duration of 12 months, however it is highly likely that it will be extended.
The main purpose of this Bioprocess Specialist position is to support first line trouble-shooting of the day to day activities within Cell Culture.
Further responsibilities of this Bioprocess Specialist role will be:
- Monitoring and troubleshooting of the commercial and clinical manufacturing processes and process optimisation
- Monitoring and reporting of process performance using statistical process control
- Generation of data and reports to support Annual Product Reviews and Regulatory submissions
- Troubleshooting of process specific equipment
- Troubleshooting of DCS (e.g Delta V) and PLC control systems
- Investigating and resolving Deviations raised within the Manufacturing Department
- Participating in/leading Cross Functional teams when required
- Support of Commissioning and Qualification activities
- Preparation and updating of Batch Records, Procedures and Work Instructions
- Providing process and equipment related training as required within the Manufacturing Department
- Completion of assigned tasks to support manufacture of quality biomedicine's in accordance with cGMP and EHS requirements.
- Working assigned shift patterns to meet business needs and manufacturing schedule.
Cell Culture Activities
- Troubleshooting of Media Preparation, filtration and storage.
- Troubleshooting of Preculture and Cell Culture
- Troubleshooting of Direct Product Capture and VIN Processing steps
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 behaviour in every activity.
- Carry out routine and non-routine tasks delegated by the Team Lead 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.
- Prioritise 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 Manufacturing Managers.
- Be familiar with daily activities in Cell Culture.
- 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
As Bioprocess Specialist, you will have the following qualifications, skills 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 Buffer or Media preparation or Equipment preparation in a manufacturing environment.
- Experience of Cell Culture either in a manufacturing or a lab based environment.
For more information or to apply for the position please contact Rob Walker on 0114 2839956 or email firstname.lastname@example.org. Alternatively, click on the link below to apply online now.
CK Science is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference SH33108 in all correspondence.