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Validation Engineer The ADL Validation department performs equipment, utility, facility, cleaning, sterilisation and packaging 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 ADL validation team for a Validation Engineer. 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 sterilisation/decontamination equipment. The sterilisation team perform /validation/ re-qualification on equipment such as VPHP isolators, autoclaves, CIP/SIP systems and Lyophilisers and provide validation oversight on aseptic processing simulations. The team also support HVAC requalification 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 to the production environment. The activities of the Validation Engineer are to :

Provide technical validation support to meet site objectives, comprising of the full validation lifecycle process.

Develop, review and approve validation plans, protocols, discrepancies summary reports

Provide support for the execution of cycle development, performance qualifications and requalification program in line with projects and site validation masterplans.

Collate and report on relevant validation data and metrics.

Assist in the development and improvements of the validation lifecycle process while ensuring continued compliance to all applicable regulations and Amgen standards. In addition, provide input and guidance into multisite and local procedural requirements.

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, when required, as a member of multidisciplinary site and multisite teams, e.g. cross functional investigation teams and change control

Update and maintain validation Standard Operating Procedures (SOPs) in accordance with site and corporate requirements.

Participate in regulatory inspections, regulatory filings

Attend and contribute to staff meetings and attend appropriate training sessions, as required.

Comply with the responsibilities as outlined in the Site Safety Statement and champion safe working practices and initiatives within their functional area.

Perform all tasks with due care and attention and in accordance with Good Manufacturing Practices and Amgen’s requirements, policies and procedures.

Basic Qualifications:

Bachelor of Science/Engineering degree or equivalent.

Knowledge of cGMP’s and other worldwide regulatory requirements.

Problem solving ability and excellent oral and written communications skills

3+ years’ experience in a similar role.

Preferred Experience:

Experience writing and executing validation documents.

Experience of 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.