Quality Facilities & Equipment Validations Specialist

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.

- Bachelor's 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.

How Jobgether works:
We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
We appreciate your interest and wish you the best!
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