GMP Validation Engineer – Equipment & Utilities

Stark Pharma Solutions Inc; Fort Washington (MD); On-site; USD 95,000 - 125,000; Full time

Job summary

Stark Pharma Solutions Inc. seeks a Validation Engineer to support IQ/OQ/PQ activities in a GMP-regulated pharmaceutical/biotech environment in Maryland.

The role entails developing protocols, documenting validation activities, and contributing to compliance initiatives. The ideal candidate has a 4+ year validation track record (or 8+ years without a degree) in GMP settings, with experience in aseptic processing, cleanrooms, sterilization equipment, and critical utilities.

Qualifications

• Bachelor's degree in engineering or related field with 4+ years in validation, or 8+ years without a degree.
• Hands-on GMP pharmaceutical/biotechnology validation experience.
• Knowledge of IQ/OQ/PQ, cGMP, GDP, and validation lifecycle.
• Experience with aseptic processing, cleanrooms, sterilization equipment, and critical utilities.
• Familiar with validation systems and data validation documentation.
• Excellent troubleshooting, documentation, and communication skills.
• Ability to manage multiple projects independently and in a team environment.

Responsibilities

• Develop, execute, and document IQ, OQ, PQ, and Requalification protocols for manufacturing equipment and utilities.
• Prepare validation reports, SOPs, risk assessments, gap analyses, and technical documentation following GDP and cGMP requirements.
• Perform thermal mapping studies using Kaye AVS or Veriteq data loggers.
• Analyze validation data and investigate deviations to ensure compliance with acceptance criteria.
• Support commissioning, FAT/SAT, equipment startup, and qualification activities.
• Assist with audits and provide technical support for manufacturing and validation investigations.
• Review validation documentation and collaborate with Engineering, Manufacturing, Quality, and Maintenance teams.

Skills

IQ/OQ/PQ knowledge

cGMP / GDP knowledge

Validation lifecycle

Troubleshooting

Cross-functional collaboration

Education

Bachelor's degree in Engineering or related field

Tools

Kaye AVS

Veriteq

EDMS

LIMS

Microsoft Office

Job description

Stark Pharma Solutions Inc. seeks a Validation Engineer to support IQ/OQ/PQ activities in a GMP-regulated pharmaceutical/biotech environment in Maryland.

The role entails developing protocols, documenting validation activities, and contributing to compliance initiatives. The ideal candidate has a 4+ year validation track record (or 8+ years without a degree) in GMP settings, with experience in aseptic processing, cleanrooms, sterilization equipment, and critical utilities.