Senior Validation Engineer

Novozen Healthcare LLC; New York (NY); On-site; USD 150,000 - 170,000; Full time

Job summary

A leading healthcare company is searching for a Senior Validation Engineer to lead the validation of critical pharmaceutical manufacturing equipment. This role involves developing protocols and ensuring compliance with industry standards. Ideal candidates will have a strong background in validation processes, excellent communication skills, and relevant educational qualifications. The position offers a competitive salary and the opportunity to collaborate with cross-functional teams in a fast-paced environment.

Qualifications

• 3–5 years of experience in validation within the pharmaceutical industry
• Hands-on experience in autoclave validation
• Working knowledge of cGMP regulations

Responsibilities

• Lead validation of pharmaceutical manufacturing equipment, including autoclaves.
• Develop and execute IQ/OQ/PQ protocols.
• Ensure adherence to FDA, EMA, and ICH guidelines.

Skills

Technical writing

Communication

Problem solving

Education

Bachelor’s or Master’s degree in Engineering, Pharmacy, Biotechnology or a related field

Tools

Electronic validation/document management systems

Job description

Direct message the job poster from Novozen Healthcare LLC

Medical Devices | Pharma | Biotechnology | Sr. Life Sciences Recruiter Email: [e-mail]

Senior Validation Engineer

Responsibilities

• Lead validation of pharmaceutical manufacturing equipment, including autoclaves and thermal processing units
• Develop and execute IQ/OQ/PQ protocols for equipment and critical utilities
• Conduct autoclave cycle development and qualification using biological and chemical indicators
• Perform troubleshooting, support deviations, CAPAs, and change control related to equipment
• Execute process validation activities for operations such as blending, granulation, compression, coating, and aseptic filling
• Support Process Performance Qualification (PPQ) and Continued Process Verification (CPV)
• Identify and monitor Critical Process Parameters (CPPs) to ensure product quality
• Collaborate with cross-functional teams in QA, manufacturing, and R&D to maintain validated state
• Prepare and maintain validation documentation in compliance with FDA, EMA, and ICH guidelines
• Ensure adherence to 21 CFR Part 11 and data integrity standards
• Support audit readiness and participate in regulatory inspections

Qualifications

• Bachelor’s or Master’s degree in Engineering, Pharmacy, Biotechnology, or a related field
• 3–5 years of experience in validation within the pharmaceutical industry
• Hands-on experience in autoclave validation and equipment qualification
• Working knowledge of process validation and lifecycle validation approaches
• Familiarity with cGMP, ICH Q8/Q9/Q10, FDA/EMA regulations
• Strong technical writing, documentation, and communication skills

Preferred Skills

• Experience with electronic validation/document management systems (e.g., Veeva, TrackWise)
• Exposure to software/system validation and data integrity concepts
• Understanding of risk assessment tools such as FMEA, HACCP, etc.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Science and Engineering

• Industries

  Pharmaceutical Manufacturing and Biotechnology Research

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