Novozen Healthcare LLC · 1 day ago
Validation Engineer
North Carolina, United States
Contract
Onsite
Senior Level
5+ years expNovozen Healthcare LLC is seeking an experienced Validation Engineer to support GMP validation activities in a pharmaceutical manufacturing environment. The role involves executing validation lifecycle activities, performing equipment validation, and ensuring compliance with FDA and global regulatory requirements.
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No H1B
Hiring Manager
TARUN KUMAR
Responsibilities
Execute and support validation lifecycle activities including URS, RA, IQ, OQ, PQ, and validation summary reports
Perform equipment validation for manufacturing, packaging, utilities, and laboratory systems
Support process validation and continued process verification (CPV)
Execute cleaning validation studies and protocols in compliance with GMP requirements
Support computer system validation (CSV) activities in accordance with 21 CFR Part 11 and GAMP 5
Participate in change control, deviation investigations, CAPA, and risk assessments
Review and approve validation-related SOPs, protocols, and reports
Collaborate with Manufacturing and Engineering teams during new equipment installation, upgrades, and technology transfers
Support regulatory inspections and audits (FDA, EMA, internal audits)
Ensure validation activities comply with FDA, cGMP, ICH, and company quality standards
Qualification
Required
Bachelor's degree in Engineering, Life Sciences, or related field
5+ years of validation experience in the pharmaceutical industry
Strong hands-on experience with GMP validation activities
Solid understanding of FDA regulations, including 21 CFR Parts 210, 211, and 11
Experience with risk-based validation approaches (ICH Q9)
Proficiency in validation documentation and technical writing
Ability to work cross-functionally in a regulated manufacturing environment
Authorization to work in the USA
Preferred
Experience in biologics, sterile manufacturing, or aseptic processing
Hands-on experience with utilities validation (HVAC, WFI, PW, compressed gases)
Familiarity with ICH Q8, Q9, Q10 guidelines
Experience supporting FDA inspections
CQV (Commissioning, Qualification, Validation) experience
Knowledge of GAMP 5 and data integrity principles
Manufacturing and packaging equipment
Cleanroom systems and HVAC
Utilities (WFI, PW, clean steam, compressed air)
Laboratory instruments
Computerized systems (MES, LIMS, SCADA, EMS)
Company
Novozen Healthcare LLC
At Novozen Healthcare, we excel in bridging the gap between academics and industry.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
Vijay Kumar
Sr. Recruitment Partner
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