Validation Engineer - Fill / Finish Equipment - Hybrid - Dun Laoghaire, Dublin
Office/Project Location:Dun Laoghaire, Dublin
Employment Type: Contract
Work Location: Hybrid
Pay: €60 - €65 per hour
Experience: 5+ years
Visa: EU passport or Stamp 4 visa required
Our client is a leading international Biotechnology company with a state of the art aseptic manufacturing facility in Dun Laoghaire, South Dublin.
The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment.
This is an excellent opportunity to get experience into Ireland's leading aseptic manufacturing plant.
The Validation department performs equipment, utility, facility, cleaning, and sterilization validation activities to ensure compliance with company procedures and industry standards in support of Operations and Quality Systems for Drug Product Manufacturing.
Role Summary:
An exciting opportunity has opened in the ADL validation team for a Senior Validation Engineer (CW). In this role, you will be responsible for delivering on the qualification and validation program at ADL, which will include planning and execution of validation/requalification activities on critical equipment. This role will focus on HVAC qualification & validation in the production environments, including managing the routine re-qualification program of airflow visualisation, filter integrity, velocity & particle monitoring testing activities as well as testing in response to changes & expansion of the production environment. This role may support (re)qualification of additional equipment on site as required (E.g. Isolators, E-Beams etc.)
Key Responsibilities:
• Provide technical validation support to meet site objectives, comprising the full validation lifecycle process.
• Develop, review, and approve validation plans, protocols, and discrepancy summary reports.
• Lead the execution of airflow visualization, filter integrity, velocity, and particle monitoring testing activities.
• Lead the execution of cycle development, performance qualifications, and requalification programs for VPHP isolators.
• Collate and report relevant validation data and metrics.
• Assist in the development and improvement of the validation lifecycle process while ensuring compliance with all applicable regulations and Amgen standards.
• Provide validation support for Amgen's quality management system, including change control, deviation, and CAPA processes.
• Coordinate projects and prioritize workload in line with site priorities.
• Participate in multidisciplinary site and multisite teams, such as cross-functional investigation teams and change control.
• Update and maintain validation Standard Operating Procedures (SOPs) in accordance with site and corporate requirements.
• Attend and contribute to staff meetings and training sessions as required.
• Comply with the responsibilities outlined in the Site Safety Statement and champion safe working practices.
• Perform all tasks with due care and attention in accordance with Good Manufacturing Practices and Amgen's requirements, policies, and procedures.
Basic Qualifications:
• Bachelor of Science/Engineering degree or equivalent.
• Knowledge of cGMPs and other worldwide regulatory requirements.
• Problem-solving ability and excellent oral and written communication skills.
• 5+ years' experience in a similar role.
Preferred Experience:
• Experience qualifying HVAC systems and/or executing VPHP qualifications.
• Familiarity with Quality and Document Management Systems, including Trackwise Deviations, CAPA and Change Controls, Maximo, CDOCs, Kneat.
• Independent, self-motivated, proactive, organized, able to multi-task in project environments, and skilled in communication and collaboration.
• Team player, prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.
Package
Contract role - Hourly rate €60 - €65 per hour
Minimum 12 month contract with the possibility of an extension.
Onsite as needed - Hybrid role