GMP Equipment Validation Engineer | Lifecycle Lead

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

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.