We are seeking a highly skilled Facilities Compliance Specialist to support a regulated environment by ensuring all facilities, utilities, equipment, and operations meet strict regulatory, safety, and quality standards. This role plays a critical part in maintaining compliance with GMP, FDA, ISO, and environmental regulations while driving validation and audit readiness across the organization.
Key Responsibilities
* Lead validation activities including IQ/OQ/PQ protocols for facilities, utilities, and equipment
* Ensure compliance with GMP, FDA, ISO, OSHA, and environmental regulations
* Develop and maintain SOPs, validation documentation, and compliance records
* Conduct internal audits and inspections, identifying gaps and driving corrective actions
* Support and participate in regulatory inspections and external audits
* Investigate deviations and non-conformances, implementing CAPA processes
* Perform risk assessments and recommend mitigation strategies
* Maintain the validated state through ongoing monitoring and revalidation activities
* Partner cross-functionally with Engineering, Quality, Manufacturing, and Facilities teams
* Develop and deliver training programs related to compliance and validation
* Ensure vendor and contractor compliance with regulatory and safety standards
* Support environmental, health, and safety (EHS) initiatives and programs
Qualifications
* Bachelor's degree in Engineering, Life Sciences, Environmental Science, or related field
* 3-5+ years of experience in validation, compliance, or facilities within a regulated environment
* Strong knowledge of GMP, FDA, ISO, OSHA, and environmental regulations
* Hands-on experience with IQ/OQ/PQ validation processes and clean utilities (e.g., HVAC, water systems)
* Experience with CAPA, risk management, and audit processes
* Proficiency in Microsoft Office and document/compliance systems
Preferred Qualifications
* Experience in pharmaceutical, biotech, or medical device industries
* Certifications such as CQA, CIA, or CRCMP
* Experience supporting regulatory audits and inspections
Key Competencies
* Strong analytical and problem-solving skills
* Excellent communication and documentation abilities
* High attention to detail and organization
* Ability to manage multiple priorities in a fast-paced environment
* Collaborative and cross-functional mindset
All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance.