MES Validation Specialist

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.