Quality Facilities & Equipment Validations Specialist

We are seeking a Quality Facilities & Equipment Validations Specialist to serve as the technical subject matter expert for Strive Pharmacy’s facility, equipment, temperature mapping, and shipping validation programs. This role will establish and maintain a structured, inspection-ready validation program that supports regulatory compliance, product quality, and continued business growth.

Key Responsibilities:

• Own and maintain the Master Validation Plan.
• Manage equipment qualification and requalification programs, including IQ/OQ/PQ.
• Oversee temperature mapping, facility certification, and shipping validation activities.
• Develop and maintain validation protocols, reports, schedules, and supporting documentation.
• Identify validation gaps and ensure corrective actions are completed.
• Track requalification and certification requirements to prevent missed deadlines.
• Partner with Quality, Pharmacy, Operations, Facilities, Engineering, and other teams.
• Support regulatory inspections and provide validation documentation and technical expertise.
• Provide validation-related training and technical guidance.
• Support validation of new equipment, systems, processes, and facilities.
• Build internal validation expertise and reduce reliance on external consultants.

Required Qualifications:

• 5+ years of experience in pharmaceutical, sterile compounding, GMP/cGMP, life sciences, or another highly regulated environment.
• Bachelor’s degree in Engineering, Life Sciences, Pharmaceutical Sciences, or a related field.
• Ability to travel up to 25% to internal facilities and industry conferences.
• Proven track record of technical writing.
• Hands-on experience with equipment qualification and validation.
• Strong understanding of IQ/OQ/PQ and validation lifecycle management.
• Experience developing or managing validation documentation.
• Strong organizational, analytical, documentation, and project management skills.
• Ability to work independently and serve as a technical resource for validation activities.

Preferred Qualifications:

• Experience managing a Master Validation Plan.
• Experience with temperature mapping, facility qualification, and/or shipping validation.
• Experience supporting regulatory inspections or audits.
• Knowledge of USP <797>, USP <800>, and applicable pharmaceutical regulations.
• Experience validating new equipment, processes, or facilities.
• Experience working with external validation consultants or vendors.

Work Environment:

This is a remote position that requires standard computer work from a home office, along with travel (up to 25%) to pharmacy cleanroom environments, laboratories, and conferences.