Validation Specialist

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 PQPerform instrument calibration and verification activities

Prepare and review technical documentation such as URS, VMP, Risk Assessments, GAP Analysis and P and IDLead 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
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