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SENIOR BIOPROCESS SPECIALIST

 

Job Reference Number

14607825

Client ID:

RI/RS 12717

Posted On:

Jun 28 2012

Location:

CORK

Job Type:

Contract

Salary:

NEGOTIABLE

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

Job Purpose:

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.

General 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
Equipment Prep Activities

  • Troubleshooting and optimization of washers and autoclaves to clean and sterilize
    equipment
  • 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

SCOPE OF RESPONSIBILITIES TO INCLUDE:

  • 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


Key Competencies:

  • Excellent interpersonal skills.
  • Ability to operate as part of a team is critical.
  • Customer focus.
  • Innovative.
  • Mechanical/Technical aptitude.
  • Excellent communication skills both written and verbal.
  • Attention to detail.
  • Good problem solving skills.
  • Results and performance driven.
  • Adaptable and flexible.


Essential Requirements:

  • 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.