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MES Validation Engineer

Apollo Professional Solutions

Hillsboro, OR

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JOB DETAILS
SKILLS
Biochemistry, Biology, Biomedical Engineering, Biotech and Pharmaceutical, Certified Quality Engineer (CQE), Chemistry, Computer Science, Computer Systems, DNA, ERP (Enterprise Resource Planning), FDA Requirements, GMP (Good Manufacturing Practices), GxP, Healthcare, Industry Standards, Laboratory Information Management System (LIMS), Manufacturing, Medical Products, Presentation/Verbal Skills, Regulations, Regulatory Compliance, Risk Analysis, Risk Management, Stem Cells, Supervisory Control and Data Acquisition (SCADA), System Operations, System Validation, Test Plan/Schedule, Test Scripts, Validation Plan, Validation Testing, Writing Skills
LOCATION
Hillsboro, OR
POSTED
30+ days ago

Join Our Team as an MES Validation Engineer – Drive Innovation and Make a Difference in Healthcare

Are you passionate about advancing cutting-edge therapies and ensuring manufacturing excellence? The Hillsboro Innovative Therapies (HIT) team at Genentech is seeking a talented MES Validation Engineer to play a pivotal role in transforming groundbreaking medical innovations—from personalized DNA/RNA therapies to cell and stem cell treatments—into life-changing medicines for patients worldwide. This is your chance to contribute to a dynamic environment where technology, compliance, and collaboration come together to shape the future of healthcare.

What You Will Do:
  • Develop, draft, and secure approval for comprehensive test scripts, validation protocols, and reports for computer systems, guaranteeing compliance with industry standards and regulations.
  • Collaborate closely with IT, Operations, Quality, and Business teams to align validation strategies with existing GMP systems.
  • Contribute to the overall validation strategy, providing expert guidance on testing approaches.
  • Execute formal validation activities within a GMP environment, ensuring systems operate reliably and safely.

Who You Are:
  • A validation professional with at least 5 years of hands-on experience developing and executing validation protocols for computer systems.
  • Skilled in Rockwell FactoryTalk PharmaSuite and familiar with validated computer systems in regulated environments.
  • Well-versed in regulatory requirements including FDA, EMA, GxP, and related standards.
  • Adept at risk assessment and mitigation for computerized systems, with a strong understanding of Computerized System Validation (CSV).
  • An excellent communicator with strong verbal and written skills.
  • Educated with a Bachelor’s degree or higher in Biomedical Engineering, Regulatory Affairs, Chemistry, Biochemistry, Technology, Biology, Computer Science, or a related life sciences field.

Nice to Have:
  • Professional certifications such as CQE, CSVS, or related credentials.
  • Experience managing testing plans and executing validation testing.
  • Familiarity with industry-specific tools like ERP systems, ValGenesis, LIMS, SCADA, and other regulated life sciences platforms.

Preferred Education & Experience:
  • Bachelor’s degree or equivalent in a relevant scientific or technical discipline.
  • Minimum of 5 years' experience in validation roles within regulated environments.
  • Proven track record working on validation projects in the biotech/pharmaceutical industry.

Other Requirements:
  • Ability to work within a GMP environment with strict adherence to regulatory compliance.
  • Flexibility to collaborate across departments and operational shifts as needed.
  • Prior experience with industry-specific validation tools is a plus.

Embark on a career where technology meets purpose—apply now to become a vital part of our innovative team and help bring life-saving therapies to patients in need.

About the Company

A

Apollo Professional Solutions

Apollo Professional Solutions was founded by Gayle A. Williams in 1983 as a technical staffing firm supporting New England aerospace companies. Today, Apollo has grown into a $40 million year company, with 5 regional offices nationwide that offers diversified support to industries that include: defense, military, aeronautical, civil, food & beverage, healthcare, marine, pharmaceutical and scientific industries, as well as local government. We are an equal opportunity employers, that is also certified as a Women’s Business Enterprise by WBENC as well as the State of Massachusetts (SOWMBA Office.)
COMPANY SIZE
100 to 499 employees
INDUSTRY
Other/Not Classified
FOUNDED
1983
WEBSITE
http://apollopros.com/

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