Validation Engineer-Media Fill
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Overview
Job Description
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 FillLocation: NCDuration: 12 MonthsPay Rate: $40/hr on W2Employment Type: Contract on W2Industry: 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
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