Overview
Team Horizon is seeking a Senior Validation Engineer for our client's facility.
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 equipment.
Why you should apply
Join a fast paced and diverse team, in a company who are committed to discovering, developing, & manufacturing innovative human therapeutics
Flexibility around remote working when the role allows
Responsibilities
Deliver on the qualification and validation program, including planning and execution of validation/requalification activities on critical equipment.
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 standards.
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 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 requirements, policies, and procedures.
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.
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.
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