Validation Team Lead-1415577W
Description
JOB DESCRIPTION
Position Title Operations-Technical Operations Validation Team Leader
Department Name Operations Department
Reports To Technical Operations Manager
POSITION SUMMARY:
The Operations Validation Team Leader is a member of the Operations –Technical Operations Validation team, playing a key role in the planning and execution of validation activities related to the Janssen Biologics (Ireland). Input into all project phases i.e. from design through to the commissioning and qualification execution phases of the project, is critical to the start-up, license approval and the on-going sustaining operations of the facility. All validation activities are conducted in compliance with US and EU legislation; as well as J&J and Janssen Standards and Guidelines to allow the facility to be qualified in accordance with the project requirements of quality, safety, schedule and budget.
GENERAL SCOPE OF RESPONSIBILITIES:
Work within the Operations – Technical Operations Validation team. Responsibilities will include, but is not limited to the following:
• Lead and conduct and validation activities in compliance with US and EU regulations, JBIL procedures and EHS requirements.
• Participate in the design of systems and equipment to ensure that they comply with cGMP requirements.
• Develop validation documentation as required (e.g. specifications, plans, protocols, procedures).
• Review and approve documents prepared by the validation team, other departments and contractor organisations (e.g. commissioning test plans, impact assessments, change controls).
• Lead the execution of qualification protocols as required.
• Compile relevant documentation from contractors, suppliers, and other departments for inclusion in reports.
• Prepare reports of executed protocols for review and approval.
• Initiate and implement change control activities in accordance with site procedures.
• Track and resolve exceptions during qualification activities.
• Prioritize qualification activities in line with the project schedule.
• Co-ordinate qualification activities with engineering, construction and commissioning activities.
• Co-ordinate qualification activities with contractors and vendors as required.
• Co-ordinate qualification document review and approval.
• Collate and organize qualification files for turnover to QADC.
• Attend identified training, required to fulfill the role of Validation Facilitator.
• Assist in the development of training material for qualification activities.
• Participate in cross-functional teams as required.
• Deputises for the Operations Technical Operations Manager when designated as appropriate.
• Domestic and international travel may be required.
KEY COMPETENCIES REQUIRED:
• Excellent interpersonal skills
• Ability to operate as part of a team is critical and also the ability to work alone as required
• Customer focus
• Excellent communication skills both written and verbal
• Attention to detail
• Good problem solving skills
• Results and performance driven
• Adaptable and flexible
Qualifications
QUALIFICATIONS AND EXPERIENCE:
ESSENTIAL:
• A degree qualification in science and/or engineering.
DESIRABLE:
• The person will have a proven track record in the qualification of any of the following systems:
o Qualification of Cell Culture Technologies.
o Qualification of Purification – Chromatography and Ultrafiltration Technologies.
o Qualification of Production Support Equipment.
o Qualification of Clean Utilities.
o Qualification of HVAC (ISO classes 5 to 8).
o Qualification of Control Systems – Emerson DeltaV, Honeywell Building Management Systems and Siemans PLCs.
o Qualification of Autoclaves
o Cleaning Validation
• Qualification experience in a project environment within the pharmaceutical or biopharmaceutical industries.
• Knowledge and Interpretation of FDA/EMEA requirements applicable to the pharmaceutical or biopharmaceutical industries. Ability to apply CGMP regulations and guidelines to all aspects of qualification activities.
KEY INDIVIDUAL CONTRIBUTOR COMPETENCIES:
Responsible for leading and directing the Validation Team
• Lead cross functional teams as defined by the site management team
• Facilitate an environment of continuous improvement
• To provide leadership and a clearly identifiable work ethos
• Collaborates effectively with JBIL and all JNJ staff, providing leadership in the activities undertaken.
• Ensure PC&D completed timely and effectively
• Demonstrates strategic thinking by maintaining a focus on project goals and global targets while meeting local and near term objectives to secure their implementation.
• To work as a strategic partner with all other departments within the company
• Manages and develops staff reporting to the position
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: Validation
Description
JOB DESCRIPTION
Position Title Operations-Technical Operations Validation Team Leader
Department Name Operations Department
Reports To Technical Operations Manager
POSITION SUMMARY:
The Operations Validation Team Leader is a member of the Operations –Technical Operations Validation team, playing a key role in the planning and execution of validation activities related to the Janssen Biologics (Ireland). Input into all project phases i.e. from design through to the commissioning and qualification execution phases of the project, is critical to the start-up, license approval and the on-going sustaining operations of the facility. All validation activities are conducted in compliance with US and EU legislation; as well as J&J and Janssen Standards and Guidelines to allow the facility to be qualified in accordance with the project requirements of quality, safety, schedule and budget.
GENERAL SCOPE OF RESPONSIBILITIES:
Work within the Operations – Technical Operations Validation team. Responsibilities will include, but is not limited to the following:
• Lead and conduct and validation activities in compliance with US and EU regulations, JBIL procedures and EHS requirements.
• Participate in the design of systems and equipment to ensure that they comply with cGMP requirements.
• Develop validation documentation as required (e.g. specifications, plans, protocols, procedures).
• Review and approve documents prepared by the validation team, other departments and contractor organisations (e.g. commissioning test plans, impact assessments, change controls).
• Lead the execution of qualification protocols as required.
• Compile relevant documentation from contractors, suppliers, and other departments for inclusion in reports.
• Prepare reports of executed protocols for review and approval.
• Initiate and implement change control activities in accordance with site procedures.
• Track and resolve exceptions during qualification activities.
• Prioritize qualification activities in line with the project schedule.
• Co-ordinate qualification activities with engineering, construction and commissioning activities.
• Co-ordinate qualification activities with contractors and vendors as required.
• Co-ordinate qualification document review and approval.
• Collate and organize qualification files for turnover to QADC.
• Attend identified training, required to fulfill the role of Validation Facilitator.
• Assist in the development of training material for qualification activities.
• Participate in cross-functional teams as required.
• Deputises for the Operations Technical Operations Manager when designated as appropriate.
• Domestic and international travel may be required.
KEY COMPETENCIES REQUIRED:
• Excellent interpersonal skills
• Ability to operate as part of a team is critical and also the ability to work alone as required
• Customer focus
• Excellent communication skills both written and verbal
• Attention to detail
• Good problem solving skills
• Results and performance driven
• Adaptable and flexible
Qualifications
QUALIFICATIONS AND EXPERIENCE:
ESSENTIAL:
• A degree qualification in science and/or engineering.
DESIRABLE:
• The person will have a proven track record in the qualification of any of the following systems:
o Qualification of Cell Culture Technologies.
o Qualification of Purification – Chromatography and Ultrafiltration Technologies.
o Qualification of Production Support Equipment.
o Qualification of Clean Utilities.
o Qualification of HVAC (ISO classes 5 to 8).
o Qualification of Control Systems – Emerson DeltaV, Honeywell Building Management Systems and Siemans PLCs.
o Qualification of Autoclaves
o Cleaning Validation
• Qualification experience in a project environment within the pharmaceutical or biopharmaceutical industries.
• Knowledge and Interpretation of FDA/EMEA requirements applicable to the pharmaceutical or biopharmaceutical industries. Ability to apply CGMP regulations and guidelines to all aspects of qualification activities.
KEY INDIVIDUAL CONTRIBUTOR COMPETENCIES:
Responsible for leading and directing the Validation Team
• Lead cross functional teams as defined by the site management team
• Facilitate an environment of continuous improvement
• To provide leadership and a clearly identifiable work ethos
• Collaborates effectively with JBIL and all JNJ staff, providing leadership in the activities undertaken.
• Ensure PC&D completed timely and effectively
• Demonstrates strategic thinking by maintaining a focus on project goals and global targets while meeting local and near term objectives to secure their implementation.
• To work as a strategic partner with all other departments within the company
• Manages and develops staff reporting to the position
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: Validation