Description
Role - Validation EngineerLocation - Dublin
Type - initially 6 month contract
One of our key Pharmaceutical clients is looking for an experienced, ‘hands-on’ Validation Engineer.
Key Responsibilities:
• Participate in design of systems and equipment, initiate and implement change control activities, coordinate validation activities with other departments
• Provide guidance on regulatory requirements and associated systems.
• Ensure systems and equipment maintain validated status.
• Provide guidance and leadership to the validation team.
• Manage the product and process life cycle
• Support internal teams with delivery on schedules
• Ensure compliance with Quality & EHS requirements
• Identify, lead and implement continuous improvement opportunities
• System/Sub System Owner or SME for Quality Management System (eg: Change Control)
• Use scientific data based problem solving, process development and validation.
• Act as SME for appropriate processes or technologies.
• Development and approval of trial protocols, hypothesis testing, validation protocols and the execution of validation testing
• Monitor progress of trials, testing and validation, and the review and approval of validation protocols and reports within the required time schedule.
• Manage the technology transfer of manufacturing processes.
Key Requirements:
• Strong previous background in process /equipment /cleaning /facility /packaging validation within the Pharmaceutical industry
• Knowledge of manufacturing sterile and solid oral dosage forms
• Demonstrated capability to lead a Departmental Project team between 1 and 10 people.
• The successful candidate will have project management experience and equipment qualification experience.
• GMP and EHS Regulations and guidelines.
• Experience with file submissions to the regulatory authorities (EMEA/FDA), audit preparations