Validation Engineer

Novozen Healthcare LLC; Maryland; On-site; USD 80,000 - 100,000; Full time

Job summary

Novozen Healthcare LLC is seeking a Validation Engineer in Maryland to support the validation and lifecycle management of GMP equipment. This role is crucial for maintaining compliance in a regulated environment and requires collaborating closely with Quality and Operations. Responsibilities include executing validation deliverables, supporting the equipment validation lifecycle, and investigating validation-related discrepancies. Applicants should have over 5 years of GMP-regulated experience, strong documentation skills, and familiarity with Blue Mountain RAM system.

Qualifications

• 5+ years of hands-on experience in GMP-regulated environments (pharma/biotech/medical device).
• Strong experience with equipment validation lifecycle (URS, IQ/OQ/PQ, RTM, reports).
• Ability to work cross-functionally with QA, Operations, and Validation teams.

Responsibilities

• Author, review, and execute validation deliverables including URS, IQ/OQ/PQ, RTM, and summary reports.
• Support full equipment validation lifecycle in a GMP-regulated environment.
• Investigate deviations, discrepancies, and CAPAs related to validation activities.

Skills

Equipment validation lifecycle

GMP-regulated environments

Cross-functional collaboration

Documentation and compliance skills

Blue Mountain RAM system

Education

Bachelor’s degree in Engineering, Life Sciences, or related field

Tools

Blue Mountain RAM system

Job description

Job Summary

We are seeking a Validation Engineer to support validation and lifecycle management of GMP equipment within a regulated environment. This role requires a hands-on professional who can own both documentation and execution, working closely with Quality, Operations, and Validation teams to ensure equipment remains in a validated and inspection-ready state.

Key Responsibilities

• Author, review, and execute validation deliverables including URS, IQ/OQ/PQ, RTM, and summary reports
• Support full equipment validation lifecycle in a GMP-regulated environment
• Perform protocol pre-reviews, execution, and ensure compliance with validation standards
• Investigate deviations, discrepancies, and CAPAs related to validation activities
• Act as an onsite point of contact for validation contractors and cross-functional teams
• Collaborate with QA, Operations, and Engineering for process improvements and updates
• Maintain validated state of equipment through periodic reviews and post-maintenance validation
• Support facility expansion, commercialization, and system upgrades
• Manage and track equipment using Blue Mountain RAM system

Required Qualifications

• Strong experience with equipment validation lifecycle (URS, IQ/OQ/PQ, RTM, reports)
• 5+ years of hands-on experience in GMP-regulated environments (pharma/biotech/medical device)
• Experience supporting deviations, investigations, and protocol discrepancies
• Ability to work cross-functionally with QA, Operations, and Validation teams
• Strong documentation, review, and compliance skills
• Experience with Blue Mountain RAM system (must-have)
• Bachelor’s degree in Engineering, Life Sciences, or related field

Preferred Qualifications

• Experience supporting facility expansions or commercialization projects
• Background in biotech or medical device industry