The Validation Lead will provide project leadership and technical expertise for the design and build phases of a new Fill/Finish facility with terminal sterilisation. 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.
For further information, please contact Brenda Fitzgerald at firstname.lastname@example.org
Renew Health Ltd. Is an equal opportunities employer.