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MES Validation Lead

A full-time MES Validation Lead, you will provide validation services for our clients in the biotech and pharmaceutical industries.

description

As a full-time MES Validation Lead you will provide validation services for our clients in the biotech and pharmaceutical industries with a focus on plant automation, specifically MES, and it’s integration with Automation, ERP systems and Quality Systems. The MES Validation Lead will lead the validation and testing of GMP compliant systems and is expected to perform various roles in the validation process, including developing the Master Validation Plan, creating and executing IQ or OQ test scripts, and performing risk assessments. In addition, this role requires close interaction with clients and the ability to work and communicate with both team members and external stakeholders.

job requirements

  • Strong background in validating systems in a FDA regulated environment.
  • Must have implementation experience with Manufacturing Executions Systems (MES) such as PAS-X, Syncade, POMSnet, PharmaSuite, or other similar systems.
  • Bachelor’s degree in a relevant area such as Operations, Computer Science, Engineering or Business Administration
  • Understanding of the validation requirements and protocols including GAMP, 21 CFR part 11 and GMP
  • Ability to travel to client sites when necessary
  • Openness to career development and feedback to promote future job advancement

Location: Remote within the United States | Stillwater, MN | Boston, MA | Chicago, IL

Travel: 40-75% based on client location (when it is safe to travel)

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North America

Enhanced Information Solutions Inc.

1725 Tower Drive, Suite 100 Stillwater, MN 55082

Europe

E.I.S. GmbH

Besselstrasse 25

68219 Mannheim, Germany

Eastern Europe and the Middle East

E.I.S. Turkey Liason Office

Göztepe Mah. Yeşilbahar Sok.

Şans Apt. No: 59 D:26 34730

Kadıköy, Istanbul, Turkey


India

Enhanced Manufacturing Information Solutions (EmIS) India, Pvt. Ltd

402, Guardian Square, Karve Rd, Erandwane, Pune, Maharashtra 411004



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