Job Title: Quality Assurance Validation Specialist
A fantastic opportunity has arisen for a Quality Assurance Validation Specialist to support new validation and commissioning activities across the site. This role involves periodic reviews of validated systems within Drug Substance, Facilities, and Laboratory environments to ensure ongoing compliance with cGLP and cGMP requirements.
You will play a key role in supporting the day-to-day operations of the Validation Department, Laboratories, and Project Teams—ensuring streamlined processes and alignment with business objectives. The role is central to driving QA compliance, maintaining best-in-class standards, and supporting specialist functions across the site.
Key Responsibilities
* Work under the direction of the QA Validation Lead in accordance with safety policies, cGMP, and cGLP.
* Collaborate with Validation, Microbiology, Engineering, IT, Utilities, and project-based teams to provide QA support for commissioning, decommissioning, and validation projects.
* Review and approve Validation Lifecycle documents and reports related to new laboratory and process equipment.
* Approve validation documentation supporting temperature mapping, EMPQ, and AVS studies.
* Provide QA oversight for periodic reviews and equipment re-validation.
* Perform real-time review of commissioning and qualification test scripts, escalating issues as needed.
* Support the site calibration program.
* Act as QA contact for Cleaning Validation, WFI PQ, equipment PQs (e.g., autoclaves, parts washers, filter integrity), and process validation studies.
* Champion data integrity initiatives across the site.
* Interpret GMP regulatory guidelines and provide quality guidance for validation activities.
* Perform additional tasks as assigned by the QA Validation Lead.
Skills & Experience Required
* Minimum BSc in a relevant Science discipline; MSc preferred.
* Minimum 1 year of experience in Validation or CQV.
Desirable Experience
* Background in Chemistry, Chemical Engineering, Biological Sciences, Biotechnology, or similar within a GMP biopharma setting.
* Knowledge of cGMP process/utility systems, deviation management, change management, and risk management.
* Experience with KNEAT, Cleaning Validation, Environmental Monitoring, Filter Validation, or Single-Use Systems.
* Understanding of regulatory guidelines (ICH, EU, FDA).
* Strong technical writing and communication skills.
* Ability to work independently, manage multiple priorities, and collaborate with global teams.