Bio Process Specialist-1400014350W
Description
Position Title Bio Process Specialist : Cell Culture
Department Operations
Reports To Cell Culture Manager
JOB DESCRIPTION
POSITION SUMMARY:
Reporting to the Manufacturing Cell Culture Manager, this position is responsible for first line trouble-shooting of the day to day activities within Cell Culture. These activities include but are not confined to:
General Activities
• Monitoring and troubleshooting of the manufacturing 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 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.
• 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
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 behavior 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.
• 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.
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.
Demonstrate Credo value of integrity
ORGANISATIONAL INTERFACES:
Interface at (Team Leader, Manager and Director level) with all site departments, Operations and Maintenance.
Contact with Quality, Logistics, OTS, Validation and Training departments. Contact with other Janssen Biologics sites sites.
Be conscious of internal customers to Manufacturing department and be cognoscente of their requirements.
Qualifications
QUALIFICATIONS AND EXPERIENCE
ESSENTIAL
• A relevant third level qualification in either Microbiology, Biochemistry, Pharmacy, Biotechnology, Science or Engineering
DESIRABLE:
• Postgraduate Qualification.
• 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.
• 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.
KEY COMPETENCIES REQUIRED:
• 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.
Significant Environmental, Health & Safety considerations:
All employees are required to comply with the requirements of the company’s Environmental, Health & Safety Policy, Safety Statement, associated EHS Procedures, local legislation and duties outlined in the site EHS Manual.
In line with the Safety Health & Welfare at Work Act (2005), all employees are required to:
• Take reasonable care to protect his or her own and the safety of their colleagues who may be affected by their actions.
• Comply with EHS rules and procedures at all times.
• Understand the potential EHS impact of their activities
• Attend and participate in EHS training as required
• Use PPE and safety equipment as required.
• Report all incidents, accidents, and near miss events.
IMPORTANT
This position description is a general guideline for colleagues, it does not purport to be an exhaustive list of all elements of the position. Management reserves the right to modify this position description at any time, or to vary the duties and responsibilities of the position to meet production, scheduling or other business needs.
Job Descriptions will be reviewed periodically.
Primary Location:Europe/Middle East/Africa-Ireland-Cork-Cork
Organization: Janssen Biologics (Ireland) (8167)
Job Function: Product Development
Description
Position Title Bio Process Specialist : Cell Culture
Department Operations
Reports To Cell Culture Manager
JOB DESCRIPTION
POSITION SUMMARY:
Reporting to the Manufacturing Cell Culture Manager, this position is responsible for first line trouble-shooting of the day to day activities within Cell Culture. These activities include but are not confined to:
General Activities
• Monitoring and troubleshooting of the manufacturing 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 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.
• 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
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 behavior 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.
• 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.
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.
Demonstrate Credo value of integrity
ORGANISATIONAL INTERFACES:
Interface at (Team Leader, Manager and Director level) with all site departments, Operations and Maintenance.
Contact with Quality, Logistics, OTS, Validation and Training departments. Contact with other Janssen Biologics sites sites.
Be conscious of internal customers to Manufacturing department and be cognoscente of their requirements.
Qualifications
QUALIFICATIONS AND EXPERIENCE
ESSENTIAL
• A relevant third level qualification in either Microbiology, Biochemistry, Pharmacy, Biotechnology, Science or Engineering
DESIRABLE:
• Postgraduate Qualification.
• 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.
• 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.
KEY COMPETENCIES REQUIRED:
• 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.
Significant Environmental, Health & Safety considerations:
All employees are required to comply with the requirements of the company’s Environmental, Health & Safety Policy, Safety Statement, associated EHS Procedures, local legislation and duties outlined in the site EHS Manual.
In line with the Safety Health & Welfare at Work Act (2005), all employees are required to:
• Take reasonable care to protect his or her own and the safety of their colleagues who may be affected by their actions.
• Comply with EHS rules and procedures at all times.
• Understand the potential EHS impact of their activities
• Attend and participate in EHS training as required
• Use PPE and safety equipment as required.
• Report all incidents, accidents, and near miss events.
IMPORTANT
This position description is a general guideline for colleagues, it does not purport to be an exhaustive list of all elements of the position. Management reserves the right to modify this position description at any time, or to vary the duties and responsibilities of the position to meet production, scheduling or other business needs.
Job Descriptions will be reviewed periodically.
Primary Location:Europe/Middle East/Africa-Ireland-Cork-Cork
Organization: Janssen Biologics (Ireland) (8167)
Job Function: Product Development