Position: Specialist, Engineering –Quality & ValidationOverview:The Specialist will be an integral member of a cross-functional team, providing technical guidance and support to ensure the success of the Quality & Validation function. This role focuses on delivering technical excellence in equipment, system, and computer system validation within a GMP-regulated environment.Key Responsibilities:Lead, execute, or participate in equipment and system lifecycle validation, including Qualification (IQ/OQ/PQ), revalidation, requalification, and periodic reviews.Coordinate and collaborate with internal departments, contractors, or vendors to complete validation tasks effectively.Participate in computer system validation (CSV) lifecycle processes, including qualification, periodic reviews, and testing activities (RS/QAP/UAT).Comply with and contribute to the Quality Management System (QMS) requirements, maintaining documentation ownership where relevant.Investigate and troubleshoot technical issues, recommending solutions or process improvements.Execute or participate in change controls, deviations, and other compliance-related tasks.Support regulatory inspections and audits as required.Lead or support shipping qualification, cleaning verification, and validation activities.Manage project schedules and workloads independently, ensuring timely completion of tasks.Provide guidance and support to colleagues in CQV (Commissioning, Qualification, and Validation) projects.Qualifications:Honours degree in a Science or Engineering discipline.Proven experience in a GMP-regulated environment.Experience:Minimum 5 years' experience in a similar role.Demonstrated knowledge of pharmaceutical or biopharmaceutical manufacturing operations, with a track record of delivering technical projects.Familiarity with regulations and standards for quality, safety, and regulatory compliance.Skills:Strong problem-solving skills with high attention to detail.Proven ability to collaborate across multiple functional teams.Demonstrated capability to deliver right-first-time results in a regulated production environment.Effective stakeholder management across multiple levels, maintaining trust and strong working relationships.