Job Description & How to Apply Below
Italy, onsite
È il candidato/la candidata ideale per questa opportunità? Lo scopra leggendo la panoramica del ruolo qui sotto. 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
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
Benefits
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.
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