Position: Specialist, Engineering –Quality & Validation
Overview:
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.