Senior Validation Engineer

Novozen Healthcare LLC; New York (NY); On-site; USD 120,000 - 180,000; Full time

Job summary

Novozen Healthcare LLC in New York seeks an experienced Senior Validation Engineer to lead equipment, process, cleaning, and CSV validation programs in a GMP environment.

You will develop validation plans, IQ/OQ/PQ, risk assessments, and support regulatory inspections while mentoring junior staff.

Strong collaboration with QA, Engineering, Regulatory Affairs, and external vendors is essential.

Qualifications

• Bachelor's degree in engineering or related field.
• 6–10 years of validation experience in pharmaceutical/biotech.
• Strong knowledge of FDA/cGMP regulations and 21 CFR Part 11.

Responsibilities

• Lead validation activities for equipment, processes, utilities, and facilities.
• Develop, review, and execute validation documents (PV plans, IQ/OQ/PQ, and final reports).
• Support C&Q activities for new equipment/facility expansions.
• Coordinate with QA, Regulatory, Manufacturing, and external vendors.

Skills

Validation leadership

Document control

Regulatory compliance

Cross-functional collaboration

Problem solving

Education

Bachelor's degree in Engineering

Tools

ValGenesis

Kneat

MasterControl

TrackWise

Job description

We are seeking an experienced Senior Validation Engineer to support validation activities in a GMP-regulated pharmaceutical manufacturing environment. The ideal candidate will lead equipment, process, utility, cleaning, and computerized system validation projects while ensuring compliance with FDA, cGMP, and global regulatory requirements. This role requires strong technical expertise, cross-functional collaboration, and the ability to manage multiple validation initiatives from planning through execution.

Key Responsibilities

• Lead validation activities for manufacturing equipment, utilities, facilities, and processes.
• Develop, review, and execute validation documentation including Validation Plans, URS, Risk Assessments, IQ, OQ, PQ protocols, and Final Validation Reports.
• Support commissioning and qualification (C&Q) activities for new equipment and facility expansions.
• Perform process validation, cleaning validation, equipment qualification, and utility qualification.
• Ensure compliance with FDA, cGMP, 21 CFR Part 210/211, EU GMP, GAMP 5, and company quality standards.
• Conduct risk assessments using FMEA or similar methodologies.
• Coordinate with Engineering, Manufacturing, Quality Assurance, Regulatory Affairs, and external vendors.
• Investigate validation deviations, implement CAPAs, and support change control activities.
• Review and approve validation documentation to ensure accuracy and regulatory compliance.
• Participate in internal audits, regulatory inspections, and client audits.
• Mentor junior validation engineers and provide technical guidance on validation best practices.
• Support continuous improvement initiatives to enhance validation processes and documentation.

Required Qualifications

• Bachelor's degree in Mechanical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology, Pharmaceutical Engineering, or a related field.
• 6–10 years of validation experience in the pharmaceutical, biologics, or biotechnology industry.
• Strong knowledge of FDA regulations, cGMP, 21 CFR Part 210/211, Annex 15, GAMP 5, and data integrity principles.
• Hands-on experience with equipment qualification (IQ/OQ/PQ), process validation, cleaning validation, and utility validation.
• Experience with manufacturing equipment such as reactors, bioreactors, filling lines, autoclaves, lyophilizers, CIP/SIP systems, HVAC, purified water systems, and clean utilities.
• Familiarity with validation lifecycle management and risk-based validation approaches.
• Excellent technical writing, documentation, and problem-solving skills.
• Strong communication and project management abilities.

Preferred Qualifications

• Experience with biologics, sterile manufacturing, or aseptic processing.
• Knowledge of computerized system validation (CSV) and 21 CFR Part 11.
• Experience using validation management tools such as ValGenesis, Kneat, MasterControl, or TrackWise.
• PMP or ASQ Certified Quality Engineer (CQE) certification is a plus.
• Experience supporting regulatory inspections by FDA, EMA, or other global health authorities.