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MES Validation Engineer

Sharp Decisions, Inc

Hillsboro, OR(remote)

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JOB DETAILS
SKILLS
Biochemistry, Biology, Biomedical Engineering, Biotech and Pharmaceutical, Business Processes, Certified Quality Engineer (CQE), Chemistry, Communication Skills, Computer Science, Continuous Improvement, Cross-Functional, DNA, ERP (Enterprise Resource Planning), FDA (Food and Drug Administration), FDA Requirements, GMP (Good Manufacturing Practices), GxP, Industry Standards, Laboratory Information Management System (LIMS), Maintain Compliance, Manufacturing, Manufacturing Execution Systems (MES), Presentation/Verbal Skills, Problem Solving Skills, Record Keeping, Regulations, Regulatory Compliance, Regulatory Requirements, Risk Analysis, Risk Management, Routing Protocols, Software Validation, Stem Cells, Supervisory Control and Data Acquisition (SCADA), System Operations, System Validation, Systems Reliability, Technical Writing, Test Plan/Schedule, Test Scripts, Test Strategy, Validation Documentation, Validation Plan, Validation Testing, Writing Skills
LOCATION
Hillsboro, OR
POSTED
11 days ago

Validation Engineer - Manufacturing Execution Systems (MES) -- 100% Remote

Summary

The Hillsboro Innovative Therapies (HIT) team is at the forefront of bringing new medical advancements from development to commercial manufacturing. This role supports the deployment and validation of Manufacturing Execution Systems (MES) used in advanced therapies, including individualized DNA/RNA therapies, cell therapies, and stem cell therapies. The Validation Engineer will play a critical role in ensuring compliance, system reliability, and operational readiness within a GMP-regulated environment.

Responsibilities

  • Develop, draft, review, and route validation protocols, test scripts, and associated reports for computerized systems.
  • Ensure validation activities comply with applicable regulatory requirements and industry standards.
  • Collaborate with IT/OT teams, system owners, quality partners, and business process owners to align validation strategies with existing GMP systems.
  • Provide input and guidance on project validation strategies and overall testing approaches.
  • Execute formal validation activities within a GMP-regulated environment.
  • Assess risks associated with computerized systems and recommend mitigation strategies.
  • Support multi-phase MES deployment initiatives and ensure compliance throughout implementation.
  • Manage testing plans, testing execution, issue tracking, and validation documentation.
  • Maintain accurate records and ensure validation deliverables meet quality and regulatory expectations.
  • Support continuous improvement initiatives related to computerized system validation and MES processes.

Required Qualifications

  • Bachelor's degree in Biomedical Engineering, Regulatory Affairs, Chemistry, Biochemistry, Computer Science, Biology, Technology, or a related life sciences discipline.
  • Minimum 5 years of experience as a Validation Professional.
  • Proven experience developing and executing validation protocols for computerized systems.
  • Strong knowledge of FDA, EMA, GxP, and industry standards related to system validation.
  • Solid understanding of Computerized System Validation (CSV).
  • Experience with Rockwell FactoryTalk PharmaSuite.
  • Strong risk assessment, analytical, problem-solving, and compliance management skills.
  • Excellent verbal and written communication skills.

Preferred Qualifications

  • Professional certifications such as Certified Quality Engineer (CQE), Certified Software Validation Specialist (CSVS), or equivalent.
  • Experience managing testing plans and validation execution activities.
  • Experience with regulated life sciences systems and platforms including ERP systems, ValGenesis, LIMS, SCADA, and Manufacturing Execution Systems (MES).
  • Knowledge of pharmaceutical, biotechnology, or advanced therapy manufacturing environments.

Key Skills

  • Manufacturing Execution Systems (MES)
  • Rockwell FactoryTalk PharmaSuite
  • Computerized System Validation (CSV)
  • GMP / GxP Compliance
  • Validation Protocol Development
  • Risk Assessment & Mitigation
  • Testing Strategy & Execution
  • FDA & EMA Regulatory Compliance
  • Quality Systems
  • ValGenesis, LIMS, ERP & SCADA Systems
  • Cross-Functional Collaboration
  • Technical Documentation

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About the Company

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Sharp Decisions, Inc

For over two decades, Sharp Decisions has provided superior, award-winning service in strategic business and technology consulting services to government agencies at all levels, as well as domestic and global corporations. With subject matter expertise in Investment Banking, Finance, Healthcare, Media & Telecommunications, and Manufacturing, Sharp Decisions is well equipped to serve your needs.

Established in 1990 with headquarters in New York City, and locations in Princeton, Charlotte, Los Angeles, Phoenix, Europe and Canada, Sharp Decisions has been the technology backbone for a client portfolio that includes an array of well-known companies. As a Certified Woman-Owned Business Enterprise and approved vendor, Sharp Decisions offers a powerful, cost-effective advantage. We actively partner with other MBEs to add value and meet diversity program requirements.

Sharp Decisions is also committed to hiring and training post-9/11, tech-savvy U.S. armed forces veterans through our V.E.T.S.â„¢ (Vocation, Education and Training for Service members) Program, but we cannot do it alone. Companies like EmblemHealth, Freddie Mac and Experian have stepped up to bring aboard our highly qualified and skilled veterans. We need more companies like them to take a stand and bring our veterans aboard. Our clients have told us that our veterans are more effective than their college hires because two weeks on the job for them equates to 2-3 years of experience! Learn more at www.sharpdecisions.com/vetsprogram.

COMPANY SIZE
500 to 999 employees
INDUSTRY
Staffing/Employment Agencies
FOUNDED
1990

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