With a need has arisen in the organisation for a Validation Engineer to represent the validation team as CSV SME for validation projects, data integrity champion, and support equipment validation activities at this growing site, at an opportune time to join the business.
Responsibilities
This role will be responsible for planning and implementing validation strategies for major capital projects.
Represent Validation at technical forums including external and internal audits.
Write, review and execute Validation Plans, Protocols and Reports for the new software and automated equipment and enterprise and SAAS / cloud-based systems.
Be a data integrity SME and champion for the site, ensuring compliance to all relevant global and local quality and validation procedures /standards. Initial requirements to focus on the areas of automation and CSV.
Supporting validation activities including review of documentation hands‑on execution of validation activities (FAT, SAT, IQ, OQ, PQ, UAT, etc) to ensure equipment / software meets current GMP requirements and industry standards.
Maintain the Site Validation Master Plan (VMP) and associated Project VMP's, defining the validation approach associated with each piece of equipment, system, process and the requalification requirements including study requirements and frequency. Execute/Coordinate Re‑Validation activities as required.
Completion of risk assessments, closure of corrective and preventive actions.
Develop alternative solutions to problems, handle highly complex problems independently. Demonstrate technical knowledge and ability to adapt to changing circumstances. Work with other departments (Operations, Quality, IT and Maintenance) to lead qualification and validation efforts in support of site projects.
Performs other validation associated activities as defined by Manager or Director.
Experience
Degree in Science/Engineering or related discipline.
Minimum of 3 years' validation experience in pharma, biotech, medical devices or diagnostics.
Hands‑on knowledge and execution of Validation.
Experience in validation of MES /EBR/LIMS and other enterprise systems (SAAS /cloud-based systems).
Experience with automated equipment (SCADA/BMS / DCS).
Experience with performing data integrity assessments and data mapping.
At least 2 years of Equipment qualification experience (GAMP, Equipment life cycle FAT, SAT, DQ, QRM, IQ, OQ, PQ).
Familiarity with cGMPs and industry and federal guidelines required.
Experience with internal (corporate) audits and external (HPRA and FDA) audits.
Experience within aseptic manufacturing environment.
PCS /DCS and automation experience
#J-18808-Ljbffr