Job Title: Validation Engineer
An exciting opportunity has opened in our client's validation team for a skilled Validation Engineer. This role involves managing the validation of computerized systems, particularly for medical devices.
Key Responsibilities:
* Provide technical validation support to meet site objectives, comprising 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.
Additional Responsibilities:
* Assist in the development and improvements of the validation lifecycle process while ensuring continued compliance to all applicable regulations and standards.
* 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.
Requirements:
* 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
$70,000 - $90,000 per year.