Validation Engineer - Cleanroom Qualification & HVAC - Dun Laoghaire, Dublin
Office/Project Location:Dun Laoghaire, Dublin
Employment Type: Contract
Work Location: Hybrid
Pay: €60 - 80 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.
An exciting opportunity has opened in the validation team for a Senior Validation Engineer.
In this role, you will be responsible for delivering on the qualification and validation program, which will include planning and execution of validation/requalification activities on critical facilities & equipment.
This role will focus on cleanroom environmental monitoring qualification to support changes & expansion of the existing production environment.
There may be a requirement to work on shift as part of this role to support critical project milestones.
Provide technical validation support to meet site objectives, comprising the full validation lifecycle process.
Develop, review, and approve validation plans, protocols, discrepancies & summary reports.
Lead the strategy development & associated risk assessments for Environmental Monitoring qualification.
Lead the planning and execution of environmental qualification activities in accordance with EU & FDA regulations including:
Environmental Qualification of Grade C cleanrooms.
Environmental Qualification of Grade A Isolator Filling Lines.
Support the execution of airflow visualization studies (smoke studies), filter integrity, velocity, and particle monitoring testing activities.
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.
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 quality management system, including change control, deviation, and CAPA processes.
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.
Requirements
Bachelor of Science/Engineering degree or equivalent. Microbiology qualification is desirable
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.
Experience qualifying cleanroom facilities and/or HVAC systems.
Familiarity with Quality and Document Management Systems, including Maximo, Veeva, and 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 - €80 per hour
Minimum 12 month contract with the possibility of an extension.
Onsite Expectations: At the beginning of the contract, a hybrid work arrangement is possible due to the project's ramp-up phase, which involves frequent meetings and planning activities.
Full-time onsite presence is not required at this stage.
However, as the project transitions to the execution phase next year and approaches key deliverables, increased onsite presence will be necessary, potentially for extended periods until the work is complete.