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Validation Quality Engineer- Miami Gardens, Fl.
Validation Quality Engineer will serve as the subject matter expert (SME) and technical owner of the Master Validation Program for PML’s manufacturing facilities. This role is responsible for authoring, executing, and overseeing validation protocols, reports, and supporting documentation to ensure facilities, utilities, manufacturing processes and equipment are qualified and compliant with OTC drug and cosmetic manufacturing regulatory standards.
The successful candidate will bring deep validation expertise, the ability to build and continuously improve systems, and a proven track record of technical problem-solving in cosmetic and OTC drug manufacturing operations. This individual will play a critical role in ensuring inspection readiness, regulatory compliance, and continuous improvement across validation programs. The ideal candidate will monitor systems, equipment and processes, often collaborating with process engineers, operations, or quality personnel, to assess processes and parameters against industry standards, establish validation standards, and develop performance testing and quality control measures to ensure compliance with FDA regulations and GMP standards.
This hands-on leadership role combines strategic and risk-based quality system management with operational oversight to ensure product safety, efficacy, and regulatory compliance throughout equipment, systems and process lifecycles. This position requires a detail-oriented leader who can balance operational excellence with regulatory requirements in a fast-paced, client-focused manufacturing environment.
Essential Duties and 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%.
Qualifications:
- 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 Skills:
- 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.
Physical Requirements:
- Ability to lift and move objects weighing up to 25 pounds regularly and occasionally heavier items with assistance.
- Ability to stand, walk, bend, stoop, push, and pull for extended periods during shifts.
- Good understanding of safety protocols and practices.
- Willingness to work flexible hours, including shifts and weekends.
- Ability to work in a fast-paced environment and adapt to changing priorities.
At Prime, we believe that a diverse, equitable and inclusive workplace makes us a more relevant, more competitive, and more resilient company. We welcome people from all backgrounds, ethnicities, cultures, and experiences. Prime is an equal opportunity employer.
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