Job Description

Role: MES Validation Engineer

Location: Portland, OR - Onsite

Duration: 12+ Months on W2 (No C2C)

Overview: Our client is seeking a skilled MES Validation Engineer to support the implementation of a new Manufacturing Execution System (MES), with a strong preference for candidates experienced in Werum PharmaSuite. These roles are critical to ensuring the system's compliance with industry regulations and successful integration within a GMP-regulated pharmaceutical environment.

Key Responsibilities:

• Author, review, and execute validation protocols, including IQ, OQ, and PQ, for MES systems.
• Develop and maintain User Requirements Specifications (URS) and other validation documentation.
• Perform system testing and support comprehensive validation activities aligned with project schedules.
• Validate Master Batch Records (MBRs) to ensure compliance with GMP standards and MES functionality.
• Work closely with cross-functional teams including Quality Assurance, IT, and Manufacturing to ensure seamless MES deployment and operation.

Qualifications:

• Demonstrated experience in MES validation within the pharmaceutical or biotech industry.
• Hands-on experience validating Master Batch Records (MBRs).
• Strong working knowledge of GMP, GAMP 5, and computer system validation best practices.
• Excellent documentation and technical writing skills.
• Ability to work independently and efficiently in a fast-paced, highly regulated environment.
• Preferred: Experience with Werum PharmaSuite MES.

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