Validation Engineer-Media Fill

We have an immediate opportunity for a Validation Engineer Media Fill with a pharmaceutical CDMO client. Please find the details below.

Job Title: Validation Engineer Media Fill
Location: NC
Duration: 12 Months
Pay Rate: $40/hr on W2
Employment Type: Contract on W2
Industry: Pharmaceutical / CDMO

Job Requirements:

• 5+ years of experience in Media Fill Validation preferred
• Strong hands-on experience with aseptic processing and sterile pharmaceutical manufacturing
• Experience planning, coordinating, and executing Media Fill / Aseptic Process Simulation (APS) studies
• Strong experience developing, reviewing, and executing validation protocols
• Experience documenting, reviewing, and analyzing media fill validation results
• Knowledge of cGMP, FDA, and global regulatory requirements
• Experience with equipment and process qualification activities
• Experience performing validation-related risk assessments
• Understanding of validation lifecycle management
• Ability to ensure validation documentation is technically sound, compliant, and inspection-ready
• Strong technical writing, documentation, and cross-functional communication skills

Key Responsibilities:

• Develop, review, and execute media fill validation protocols
• Coordinate and execute Media Fill / APS studies within sterile manufacturing operations
• Review and analyze validation results and prepare associated documentation
• Support aseptic process validation and sterile manufacturing activities
• Perform risk assessments and support investigation of validation issues or deviations
• Support equipment and process qualification
• Maintain validation lifecycle documentation in accordance with established quality requirements
• Collaborate with Manufacturing, Quality, Engineering, and Validation teams
• Ensure validation activities comply with cGMP, FDA, global regulatory, and company quality standards

Primary Skills: Media Fill Validation, Aseptic Processing, APS, Sterile Manufacturing, Process Validation, Validation Protocols, Equipment Qualification, Risk Assessment, cGMP, FDA Compliance