Prime Matter Labs · 3 months ago
Validation Quality Engineer- Miami Gardens, Fl.
Miami Garden, FL
Full-time
Onsite
Mid Level
3+ years expPrime Matter Labs is seeking a Validation Quality Engineer to serve as the subject matter expert and technical owner of the Master Validation Program for their manufacturing facilities. The role involves authoring, executing, and overseeing validation protocols and documentation to ensure compliance with regulatory standards in OTC drug and cosmetic manufacturing.
Manufacturing
Responsibilities
Develop, implement, and maintain PML’s Master Validation Program at PML’s facilities
Lead and support commissioning, qualification, and validation (IQ/OQ/PQ) activities for facilities, utilities, manufacturing processes and equipment
Author, review, and execute validation documentation including protocols, reports, project plans, risk assessments, CAPAs, deviations, and change controls
Serve as SME for validation within the change control process, providing technical oversight and guidance across cross-functional teams
Assist in management and continuous improvement of calibration programs, ensuring adherence to schedules and regulatory requirements
Develop and report on key metrics related to areas of responsibility, including statistical analysis as needed
Lead and/or assist in investigations and resolution of quality issues through root cause analyses and determined corrective/preventive action (CAPA) initiatives
Assist in developing, monitoring, and acting on process data to drive continuous improvement
Support audit and inspection readiness by presenting validation activities to regulatory authorities and customers; lead responses and corrective actions as required
Partner with Quality, Manufacturing, Engineering, and site leadership to resolve technical issues, support process improvements, and foster a culture of compliance
Maintain and demonstrate expertise in applicable regulatory requirements GMP, FDA regulations (21 CFR Parts 11/210/211), and ISO 22716 for cosmetics and OTC drug products
Develop, review, write, and implement SOPs for quality validation functions
Drive collection, analysis and trending of validation data, reports or Quality metrics
Aids in internal audit program, as well as regulatory and customer audit inspection readiness
Provides training for other departments as needed
Train and mentor cross-functional teams on validation and best practices
Willingness to travel to company facilities as needed, up to 50%
Qualification
Required
Bachelor's degree in Engineering or related field
Minimum 3 years as a validation engineer in a regulated manufacturing environment preferred (cosmetics or OTC drugs a plus)
Extensive experience in equipment calibration and performance testing, advanced proficiency in data analysis tools and project management software, and in-depth knowledge of production processes and standards
Exceptional analytical and problem-solving abilities, excellent leadership, communication and technical writing skills, and strong organizational abilities
Proven ability to work in a fast-paced, client-focused environment
Preferred
Working knowledge of quality systems and regulatory requirements (21 CFR Part 11/ 210 / 211), including data integrity practices
Experience working with cross-functional technology teams and enterprise systems
Exceptional problem-solving skills, attention to detail, and the ability to manage multiple priorities in a fast-paced environment
Strong attention to detail and organizational skills
Effective written and verbal communication skills
Proficiency in Microsoft Office and familiarity with electronic quality systems
Company
Prime Matter Labs
Prime Matter Labs is a contract manufacturers of beauty and personal care products.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Aaron Paas
Chief Executive Officer
Recent News
2026-01-16
2024-10-16
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