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. Powered by JazzHR
Create a job alert for this search
Quality Engineer • Miami Garden, FL, US
Related searches
Related jobs
Quality Engineer
Jobot • Miami Gardens, FL, US
Permanent
Bilingual, Quality Engineer role for local Manufacturing company - Affordable Benefits, HRA, 401k match, etc.This Jobot Job is hosted by : Jennifer Sabo.
Are you a fit? Easy Apply now by clicking the...Show more
Last updated: 21 days ago • Promoted
Quality Engineer
SHL Group • Deerfield Beach, FL, US
Full-time
Deerfield Beach, United States of America.SHL Medical is a world-leading provider in the design, development, and manufacturing of advanced self-injection devices.
With a global team of 6,000 employ...Show more
Last updated: 9 hours ago • Promoted • New!
QA Engineer
HelloGov AI • Miami, FL, US
Full-time
Quick Apply
We’re looking for a detail-oriented QA Engineer to join our team in Miami.In this role, you’ll be the guardian of product quality — monitoring errors, logs, and real-world usage to identify issues ...Show more
Last updated: 30+ days ago
Lead QA Engineer
ClinDCast LLC • Delray Beach, FL, US
Full-time
Location : Boston, MA (On-site).Were seeking a Lead QA Engineer to ensure the quality and reliability of our Portfolio Analysis & Management Platform.
Youll lead test automation efforts, translat...Show more
Last updated: 30+ days ago • Promoted
Lead Quality Assurance Engineer
ITrade STEM • Miami, FL, US
Full-time
We do this by creating programs that teach skills and support sustainable growth.Join us on our mission to Redefine STEM!.
Lead Quality Assurance Engineer.Our client is a leader in Web3 innovation, ...Show more
Last updated: 30+ days ago • Promoted
Validation Engineering Manager
PSC Biotech • Miami, FL, us
Full-time
Quick Apply
PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all appl...Show more
Last updated: 15 days ago
Lead Quality Assurance Engineer
ITRADE STEM • Miami, FL, US
Full-time
AT ITRADE Innovations, we help create jobs and support the future of industries like space, technology, energy, and manufacturing.
We do this by creating programs that teach skills and support susta...Show more
Last updated: 30+ days ago • Promoted
Engineer
GA Telesis, LLC • Medley, FL, US
Permanent
Quick Apply
GA Telesis is a global leader providing integrated solutions to the aviation and aerospace industries.We serve over 2,000 customers, including airlines, original equipment manufacturers, maintenanc...Show more
Last updated: 16 days ago
Quality Engineer
VirtualVocations • Hialeah, Florida, United States
Full-time
A company is looking for a Staff Development Quality Engineer in New Port Richey, FL.Key Responsibilities Perform audits, inspections, tests, defect analysis, and trend analysis to assure quality...Show more
Last updated: 30+ days ago • Promoted
Sr. Product Quality Engineer
Executive Avail-A-Search • Fort Lauderdale, FL, US
Full-time
Product Quality Engineer – Fort Lauderdale, FL The Opportunity Our client, a global equipment manufacturer, has hired us to find a Sr.
Product Quality Engineer for their Fort Lauderdale, FL location...Show more
Last updated: 1 day ago • Promoted
Level I - MRI Technologist
University of Miami • Miami Beach, FL, US
Full-time
University of Miami is seeking a MRI Technologist Level I for a job in Miami Beach, Florida.Job Description & Requirements.
The University of Miami UHealth Department of Imaging Services has an ...Show more
Last updated: 14 days ago • Promoted
Quality Engineer III
VirtualVocations • Fort Lauderdale, Florida, United States
Full-time
A company is looking for a Quality Engineer III.Key Responsibilities Develop and execute software quality methods and processes Lead projects and mentor less experienced team members in quality ...Show more
Last updated: 30+ days ago • Promoted
Validation Specialist
BioStem Technologies (OTC : BSEM) • Pompano Beach, FL, US
Full-time
Get AI-powered advice on this job and more exclusive features.Direct message the job poster from BioStem Technologies (OTC : BSEM).
Senior Human Resources Business Partner BioStem Technologies.Throug...Show more
Last updated: 9 hours ago • Promoted • New!
Lead Quality Assurance Engineer
Octagon Talent • Aventura, FL, US
Full-time
Octagon Talent Solutions is a full-service technology recruitment and staffing company based in South Florida.We humanize technical recruitment by identifying candidates' long-term career goals...Show more
Last updated: 30+ days ago • Promoted
Quality Assurance Engineer IV
VirtualVocations • Hollywood, Florida, United States
Full-time
A company is looking for an Engineer IV focused on Quality Assurance.Key Responsibilities Design, develop, implement, and maintain comprehensive test plans, test cases, and automated test suites ...Show more
Last updated: 11 hours ago • Promoted • New!
Supplier Quality Engineer
TRIGO ADR Americas • Miami, FL, US
Full-time
Quick Apply
The Supplier Quality Engineer will be responsible for executing and expanding on key initiatives inside of the supplier quality organization.
The Supplier Quality Engineer will be responsible for ex...Show more
Last updated: 15 days ago
Quality Engineer
HEICO • Hollywood, FL, US
Full-time
Quality Assurance Specialist at HEICO within the Technical Services (TS) organization, providing quality and engineering oversight, guidance, and assistance to Business Units within HEICO Parts Gro...Show more
Last updated: 9 hours ago • Promoted • New!
Quality Engineer
Leeds Professional Resources • Tamarac, FL, US
Full-time
Leeds Professional Resources is working with a client that is looking for a Quality Engineer to join their growing team.The Quality Engineer develops, establishes, and maintains quality systems and...Show more