MES Validation Specialist Job at Intellectt Inc, Portland, OR

RFVPZ2o0WDRTN2hCWnp2L0Nla2VFOG1PaXc9PQ==
  • Intellectt Inc
  • Portland, OR

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.

Job Tags

Similar Jobs

Zenith LifeScience

Research Assistant Job at Zenith LifeScience

 ...methods, SOPs and/or other documents as appropriate. Participate in tracking assay results and test method performance parameters. Assist in everyday operation of analytical laboratories, including but not limited to equipment management, lab maintenance and restocking... 

Peckham Industries

Senior Network Engineer Job at Peckham Industries

 ...Job Summary: As a Senior Network Engineer, you will be expected to be an IT infrastructure professional with expertise in designing, building, and supporting enterprise environments. Well versed in managing and supporting Microsoft Azure, SonicWALL/Fortinet firewalls... 

Disc Replay

Video Game Store Manager Job at Disc Replay

 ...when you succeed? If so, you could be a great fit for our Store Manager position at Disc Replay! At Disc Replay, we buy and sell video games, movies, electronics, and collectibles. Our customers bring us cool stuff all day long. We pay cash on the spot to buy their... 

Ace Equipment Company

General Laborer Job at Ace Equipment Company

Titus Talent Strategies has partnered with ACE Equipment Company as they look to hire a General Laborer for their new facility in the heart of Antigo. Build with Purpose. Grow with Us. At ACE Equipment Company , were a family-owned manufacturer of waste compactors...

Visible

Technical Co-Founder / CTO Job at Visible

Im on a mission to take Visible to the next level. Our product is already live, gained traction, and now Im looking to grow our team by bringing on a hands-on passionate, skilled, and driven Technical Co-Founder / CTO with expertise in Flutter. Together, we can make...