Job Description
An exciting opportunity has opened in my client's validation team for a Validation Engineer. This role involves managing the validation of computerized systems, particularly for medical devices. Responsibilities include creating and reviewing validation documentation in compliance with industry standards and regulatory guidelines.
Role and Responsibilities:
- 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.
- Utilise engineering, vendor, and customer specifications to create and execute testing protocols for equipment, following company and customer procedures and good documentation practices.
- Maintain attention to detail and a thorough understanding of pharmaceutical processes, automation processes, equipment, and systems.
- 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 standards. In addition, provide input and guidance into multisite and local procedural requirements.
- Provide validation support for 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.
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 in equipment qualification and the validation lifecycle.
- 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
For more information please contact or call 0212300446.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.
