Validation Lead Engineer
The Validation Lead will provide project leadership and technical expertise for the design and build phases of a new Fill/Finish facility with terminal sterilization. The person will support the development and maintenance of the site validation program. This role includes support for the design, start-up, commissioning and qualification of equipment and associated computer systems, facilities, and utility systems.
The role is for a client-side lead to work with equipment vendors to lead and support the CQV lifecycle activities as part of a new facility start-up project. Responsible for commissioning and qualification of cGMP equipment and associated computer systems, facilities, and utilities. Validation responsibilities include oversight for the following;
- (Equipment systems); cleaning, sterilisation and sterile hold. CQV through to PQ, cycle development and commercial batch release.
- (Facility Systems); Architectural finishes, classified space, environmental and building management system qualification.
- Responsible for developing and executing commissioning and qualification documentation for new systems and equipment. This will include supporting the complete CQV lifecycle; Writing URS documents, review / approval of Design Specifications, input into the control strategy, development and execution of the test matrix (leveraged) to support offsite / onsite execution (as per ASTM E2500).
- Experience of working with equipment vendors to develop and execute the CQV lifecycle.
- Knowledge of utilising a ‘best practise’ methodology to help deliver a science and risk-based approach to CQV for a green field project start-up.
- The candidate should have strong leadership, direction and organisational planning skills to support the team through each stage of the project.
- The candidate should have direct experience of engaging with and presenting to the regulatory authorities including the FDA and HPRA.
- The role includes the need to develop and support the implementation of site procedures for a robust and compliant commissioning, qualification, and validation Program.
- Self-motivated and passionate starter.
- Team player who embraces collaboration for project success.
- Ideally degree qualified; in Engineering, technical or science related field.
- 5+ years of progressive experience in CQV role within a pharmaceutical (fill / finish & terminal sterilsation) operation, including a thorough working knowledge of EU GMPs, FDA cGMP, GAMP5, ICH guidelines, and validation principles.