Location: Italy, onsite
We're looking for a Validation specialist for our existing consulting company specialising in engineering and validation services for the pharmaceutical and biotechnology sectors is seeking an experienced Validation Specialist to support client projects across Italy. This role requires an onsite presence and offers the opportunity to work on complex, high value projects within regulated GMP environments.
Responsibilities
* Draft and execute qualification and validation protocols including IQ, OQ and PQ
* Perform instrument calibration and verification activities
* Prepare and review technical documentation such as URS, VMP, Risk Assessments, GAP Analysis and P and ID
* Lead and support qualification of HVAC systems and cleanroom environments
* Execute validation activities for critical utilities including Purified Water, Water for Injection and Clean Steam
* Conduct qualification of process equipment including RABS, isolators, autoclaves and freeze dryers
* Coordinate with clients, suppliers and multidisciplinary project teams to ensure successful project delivery
* Maintain compliance with GMP standards and regulatory requirements
Requirements
* Demonstrated experience as a Validation Specialist within the pharmaceutical or biotechnology industry
* Strong knowledge of GMP regulations, ideally with exposure to EU GMP and or FDA guidelines
* Hands on experience with equipment, utilities and process validation
* Ability to manage documentation in a structured and compliant manner
* Strong communication skills with the ability to work effectively across teams and stakeholders
* Fluent English is required. Italian would be advantageous
Offer
* Opportunity to join a well established consultancy delivering projects across the pharma and biotech sector
* Onsite work with leading clients in regulated environments
* Exposure to international and technically challenging projects
* Competitive salary and benefits package based on experience