SENIOR BIOPROCESS SPECIALIST
Senior Bioprocess Specialist
We are currently recruiting a Senior Bioprocess Specialist for a role based in Cork.
PLEASE NOTE THIS IS A 12 MONTH FIXED TERM CONTRACT ROLE
Responsible for first line trouble-shooting of the day to day activities within either Cell Culture, Purification or Equipment Prep. You will be reporting to the relevant Operations Team Leader.
Equipment Prep Activities
- Monitoring and troubleshooting of the Operations processes and process optimization
- 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 Operations 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 Operations Department
- Completion of assigned tasks to support manufacture of quality biomedicines in accordance with cGMP and EHS requirements
- Working assigned shift patterns to meet business needs and Operations schedule Cell Culture Activities
- Troubleshooting of Media Preparation, filtration and storage.
- Troubleshooting of Preculture and Cell Culture Purification Activities
- Monitoring and Troubleshooting of Buffer Preparation
- Monitoring and Troubleshooting Column Packing activities
- Monitoring and Troubleshooting of DPC and Purification of product
- Monitoring and Troubleshooting of Final filtration, filling and finishing of purified product
- Management and control of Purification process database
SCOPE OF RESPONSIBILITIES TO INCLUDE:
- Troubleshooting and optimization of washers and autoclaves to clean and sterilize
- Troubleshooting and optimization of COP and SOP booths and CIP skids
- Troubleshooting and optimization of decontamination autoclaves
- Develop and implement systems and procedures in the equipment preparation and weigh dispense areas
- Monitoring and responding to changes in business, operational, and quality metrics
- Optimize throughput in equipment preparation and weigh dispense areas
- Travel to other sites for business relevant activities as required.
- 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 Team Leader according to appropriate procedures, values and standards
- Carry out all activities in compliance with corporate and cGMP/EHS regulatory requirements
- Compliance with Operations and general site procedures at all times.
- Actively participate in PC&D process
- 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 provide 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
- Participate in Emergency Response/Fire/First Aid teams as necessary
- Generate and assist with generation, review and revision of Operations documentation as necessary
- Ensure that personal training requirements are completed in compliance with site procedures.
- Training and support for new recruits to the Operations group
- Support ongoing studies by Validation, OTS and other support functions
- Excellent interpersonal skills.
- Ability to operate as part of a team is critical.
- Customer focus.
- Mechanical/Technical aptitude.
- Excellent communication skills both written and verbal.
- Attention to detail.
- Good problem solving skills.
- Results and performance driven.
- Adaptable and flexible.
- The successful candidate will have a relevant third level qualification in either Microbiology, Biochemistry, Pharmacy, Biotechnology, Science or Engineering (Postgraduate Qualification is Desirable) with at least 8 years experience in a similar role.
- Operations experience within a GMP regulated environment essential.
- Experience of Buffer or Media preparation or Equipment preparation in an Operations environment is essential .
- Experience in column packing and equipment preperation is essential
- Experience of Cell Culture or Protein Purification, either in an Operations or a lab based environment.
- Experience of Microsoft Word, Excel, Outlook, 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.