Validation Expert

About the Position

We are looking for Validation Manager is responsible for hands-on management and execution of all validation and calibration activities at the manufacturing site. This is a highly hands-on role that involves direct execution of validation activities in the field, authoring and approving validation documentation, close daily interaction with production, labs and engineering teams, and professional management of external contractors and vendors.

The role requires high independence, strong ownership, and end-to-end responsibility, from planning through execution and final reporting.

Key Responsibilities

Hands-On Validation Execution

• Plan, execute, and approve validation activities for equipment, systems, and manufacturing processes
• Perform hands-on IQ / OQ / PQ activities on the manufacturing floor
• Validate:
• Manufacturing and packaging equipment
• Utilities (HVAC, water systems, compressed air, gases)
• Cleanrooms
• Labs equipment’s
• Computerized systems (CSV – as applicable)
• Support equipment installation, FAT / SAT, and introduction of new equipment

Documentation and Compliance

• Hands-on authoring of:
• Validation protocols
• Validation reports
• Risk assessments (FMEA)
• SOPs
• Review and approve validation and quality documentation
• Own, maintain, and update the Validation Master Plan (VMP)

Shop Floor & Manufacturing Support

• High level of presence on the manufacturing floor
• Ongoing support to production during changes, deviations, and troubleshooting
• Analysis of processes, yields, and statistical data
• Support technology transfer and New Product Introduction (NPI) from development to commercial manufacturing

Contractors and Vendors Management

• Hands-on professional management of validation and calibration contractors
• Direct interaction with equipment suppliers, service providers, and external laboratories
• Review and control of contractors’ execution quality and deliverables

Quality & Regulatory Activities

• Manage deviations, investigations, and CAPAs related to validation
• Lead Change Controls associated with equipment and processes
• Prepare for and actively participate in regulatory inspections (FDA, EMA, internal audits)

Qualifications & Requirements

Education & Experience

• BSc in Engineering, Life Sciences, or a related field – mandatory
• Minimum of 5 years of hands-on validation experience in a GMP environment – mandatory
• Proven experience performing validations directly (not only managing)

Technical Expertise

• Strong knowledge of GMP and pharmaceutical regulatory requirements
• Full understanding of the validation lifecycle
• Experience with manufacturing equipment, utilities, and production systems

Personal Skills

• Strong hands-on mentality and willingness to execute independently
• High level of initiative, ownership, and accountability
• Ability to work independently in a fast-paced, multi-task environment
• Excellent interpersonal and cross-functional communication skills

Languages

• English – high level of reading and writing (mandatory)
• Hebrew – high level