Novozen Healthcare LLC · 2 hours ago
Process Validation Engineer
Indiana, United States
Contract
Onsite
Mid, Senior Level
4+ years expNovozen Healthcare LLC is seeking a Process Validation Engineer responsible for planning, executing, and maintaining process validation activities in compliance with FDA, cGMP, and global regulatory requirements. This role supports manufacturing operations by ensuring pharmaceutical processes are capable, controlled, and compliant throughout the product lifecycle.
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Hiring Manager
TARUN KUMAR
Responsibilities
Lead Process Validation lifecycle activities including Process Design, Process Qualification (PPQ), and Continued Process Verification (CPV)
Develop, execute, and review validation protocols and reports (IQ/OQ/PQ/PPQ) for pharmaceutical manufacturing processes
Collaborate with Manufacturing, MSAT, Quality, Engineering, and Regulatory teams to support validation strategies
Perform risk assessments (FMEA, risk matrices) to identify critical process parameters (CPPs) and critical quality attributes (CQAs)
Support technology transfers, scale-up, and new product introductions (NPI)
Analyze process data and trends; support statistical analysis and CPV reporting
Investigate process deviations, non-conformances, and CAPAs related to validated processes
Ensure compliance with FDA, EU, ICH, and cGMP guidelines
Support regulatory inspections and audits by providing validation documentation and technical justification
Maintain validation documentation in accordance with site SOPs and quality systems
Qualification
Required
Bachelor's degree in Chemical Engineering, Mechanical Engineering, Biotechnology, Pharmacy, or related discipline
4–6 years of hands-on experience in Process Validation within the pharmaceutical or biologics industry
Strong working knowledge of cGMP, FDA regulations, ICH Q8/Q9/Q10, and validation lifecycle concepts
Experience with PPQ execution, CPV programs, and commercial manufacturing support
Familiarity with statistical tools and data analysis (Minitab or equivalent)
Experience working in regulated manufacturing environments (oral solids, injectables, biologics, or sterile manufacturing preferred)
Excellent documentation, communication, and cross-functional collaboration skills
Preferred
Experience with aseptic processing, sterile manufacturing, or biologics processes
Prior involvement in FDA or regulatory inspections
Knowledge of MES, electronic batch records, and validation tracking systems
Lean / Six Sigma or quality certification is a plus
Company
Novozen Healthcare LLC
At Novozen Healthcare, we excel in bridging the gap between academics and industry.
201-500 employees
H1B Sponsorship
Novozen Healthcare LLC has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (47)
2024 (34)
2023 (20)
2022 (1)
Funding
Current Stage
Growth StageLeadership Team
Vijay Kumar
Sr. Recruitment Partner
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