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Apollo Professional Solutionshttps://www.apollopros.com/wp-content/uploads/2022/05/ApolloLogo600.pnghttps://www.apollopros.comhttps://www.apollopros.comUSD6171HOURtrue
Contract MES Validation Lead Location: Hillsboro, OR | On-Site | Contract Position
We’re looking for an experienced MES Validation Lead to join a high-impact team driving the implementation of Manufacturing Execution Systems (MES) at a state-of-the-art biologics manufacturing facility. This is a unique opportunity to help advance the deployment of cutting-edge therapies including DNA/RNA-based treatments, cell therapies, and stem cell technologies. You'll lead validation efforts during a multi-phase MES rollout and help integrate automation that improves efficiency and patient outcomes. Position Overview: As MES Validation Lead, you will play a critical role in ensuring the successful validation of MES systems and related processes. You'll collaborate closely with cross-functional teams—including IT/OT, quality, system owners, and process stakeholders—while managing a dedicated team and overseeing all validation-related deliverables. Key Responsibilities:
Lead and coordinate the MES validation team, ensuring deliverables are completed on time and escalate issues as needed.
Define and document the overall validation strategy for the MES deployment in alignment with GMP and regulatory requirements.
Collaborate with quality assurance, IT/OT, system owners, and business process owners to ensure seamless integration with existing validated systems.
Draft, review, and route validation protocols and reports for computerized systems in compliance with GxP and industry standards.
Ensure validation-related change controls, testing records, and documentation align with project and compliance expectations.
Guide the development and execution of test strategies, oversee testing activities, and ensure traceability of system requirements.
Provide hands-on support to secure a smooth transition to business operations post go-live.
Take ownership of change records and quality documentation as required throughout the validation lifecycle.
Qualifications:
Bachelor’s degree or equivalent in Biomedical Engineering, Regulatory Affairs, Chemistry, Biochemistry, Biology, Technology, or related life sciences field.
Minimum 5 years of experience in computerized system validation within a regulated life sciences environment.
Strong understanding of FDA, EMA, GxP requirements and industry standards for system validation.
Proven experience developing and executing validation protocols (IQ/OQ/PQ) for MES or similar systems.
Expertise in test planning, test execution oversight, and requirements traceability.
Skilled in managing validation teams and coordinating cross-functional project efforts.
Familiarity with regulated platforms such as ERP systems, LIMS, SCADA, and other manufacturing technologies.
(Preferred) Professional certifications such as CQE or CSVS.
This contract role is ideal for someone passionate about innovation in life sciences and experienced in delivering high-quality validation processes within a GMP-regulated environment. You’ll be part of a forward-thinking team helping to bring life-changing therapies to patients faster and more safely.
EEO Statement Apollo Professional Solutions, Inc. is an equal opportunity employer. We provide equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, marital status, age, national origin, ancestry, disability status, medical condition, pregnancy, genetic information, protected veteran status, gender, sexual orientation, gender identity or expression, or any other status or characteristic protected under federal, state, or local law.
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