Validation Specialist
PhytogenX is growing, and we’re looking for a skilled Validation Specialist to join our team! In this role, you’ll ensure that our manufacturing processes, equipment, utilities, computerized systems, and cleaning procedures meet all applicable FDA cGMP requirements for topical OTC drugs and industry standards for personal care products. You’ll play a key part in new product introductions, technology transfers, and ongoing commercial manufacturing within a dynamic contract manufacturing environment.
Key Responsibilities
Develop, execute, and maintain validation protocols and reports for process, cleaning, equipment, utilities, and computerized systems (CSV).
Ensure compliance with FDA cGMP requirements (21 CFR Parts 210/211).
Support continued process verification and revalidation activities.
Collaborate with Manufacturing, Engineering, R&D, and Quality teams to support new product launches and technology transfers.
Participate in risk assessments (e.g., FMEA).
Support deviations, CAPAs, and change control processes.
Maintain validation master plans and schedules.
Support FDA inspections and customer audits.
Identify and implement opportunities for improving the validation lifecycle.
Education & Experience Requirements
Bachelor’s degree in engineering, chemistry, pharmaceutical sciences, biology, or a related field.
2 to 5 years of experience in validation within pharmaceutical, OTC, cosmetic, or personal care manufacturing.
2 to 3 years of process and cleaning validation experience.
Strong understanding of FDA cGMP (21 CFR 210/211) and risk-based validation approaches.
Experience working with topical dosage forms.
Skills & Competencies
Strong technical writing and organizational skills.
Excellent attention to detail and focus on data integrity.
Effective cross-functional collaboration skills.
Strong problem-solving and communication abilities.
Demonstrated reliability, dependability, and strong attendance record.
Ability to manage multiple priorities in a fast-paced environment.
Preferred Qualifications
Experience in a CMO/CDMO environment.
Exposure to FDA inspections and customer audits.
Experience with computer software validation (CSV) or automation.
Familiarity with ISO 22716.
Physical Demands
Office-based work with regular time spent in manufacturing, warehouse, laboratory, and utility areas.
Ability to sit, stand, and walk for extended periods during validation activities.
Occasional bending, stooping, kneeling, and reaching to inspect equipment or processes.
Ability to lift up to 25 lbs (binders, laptops, sampling tools, validation equipment).
Manual dexterity to operate computers, instruments, and validation tools.
Ability to wear required PPE including lab coats, safety glasses, gloves, hair nets, and safety shoes.
Ability to work in controlled environments with potential exposure to noise, temperature variations, cleaning agents, and chemical vapors.
Personal Care Product Manufacturing
Quality Assurance
Full-time