Quality Facilities & Equipment Validations Specialist

Team: Others

Location: US

Commitment: Full-time

Workplace Type: remote

Accountabilities:

• Own and maintain the Master Validation Plan, ensuring validation activities remain structured, current, and inspection-ready.
• Manage equipment qualification and requalification programs, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Oversee temperature mapping, facility certification, shipping validation, and related qualification activities.
• Develop, maintain, and organize validation protocols, reports, schedules, and supporting documentation.
• Identify validation gaps, coordinate corrective actions, and ensure remediation activities are completed on schedule.
• Track requalification, certification, and validation requirements to prevent missed deadlines and compliance gaps.
• Partner with Quality, Pharmacy, Operations, Facilities, Engineering, and other stakeholders on validation initiatives.
• Support regulatory inspections and audits by providing validation documentation, technical expertise, and timely responses.
• Provide validation-related training and technical guidance to internal teams.
• Support the validation of new equipment, systems, processes, and facilities throughout their lifecycle.
• Build internal validation capabilities and expertise while reducing reliance on external consultants and vendors.
• Maintain accurate records and provide technical and organizational support for ongoing validation projects.

Requirements:

• 5+ years of experience in pharmaceutical, sterile compounding, GMP/cGMP, life sciences, or another highly regulated environment.
• Bachelors degree in Engineering, Life Sciences, Pharmaceutical Sciences, or a related discipline.
• Hands-on experience with equipment qualification and validation, including strong knowledge of IQ/OQ/PQ principles and validation lifecycle management.
• Proven experience developing, reviewing, or managing validation protocols, reports, schedules, and related documentation.
• Demonstrated technical writing skills with strong attention to accuracy, clarity, and regulatory requirements.
• Strong organizational, analytical, documentation, and project management capabilities.
• Ability to independently manage validation activities and serve as a trusted technical resource for internal teams.
• Experience managing a Master Validation Plan is preferred.
• Experience with temperature mapping, facility qualification, and/or shipping validation is preferred.
• Experience supporting regulatory inspections or audits is an advantage.
• Knowledge of USP <797>, USP <800>, and applicable pharmaceutical regulations is preferred.
• Experience validating new equipment, processes, or facilities is beneficial.
• Experience working with external validation consultants or vendors is a plus.
• Ability and willingness to travel up to 25% to internal facilities and industry conferences.
• Comfortable working remotely from a home office while traveling periodically to pharmacy cleanrooms, laboratories, and other professional environments.

Benefits:

• Annual salary of $115,000–$135,000 USD.
• Remote, full-time position for professionals residing in the United States.
• Employer-paid healthcare coverage, effective the first day of the month following your hire date.
• Free compounded medications for employees when supported by a valid patient-specific prescription from a licensed healthcare provider.
• Paid time off and sick time.
• Flexible Spending Account (FSA) and Health Savings Account (HSA) options.
• Paid parental leave.
• 401(k) retirement plan with employer matching.
• Life insurance.
• Dental and vision insurance.
• Veterinary insurance.
• Opportunities for professional development and cross-functional collaboration.
• Remote work environment with approximately 25% travel to facilities and industry conferences.