MES Validation Engineer
4 days ago
Valspec, a global leader in system validation and lifecycle services, is seeking a highly skilled MES Validation Engineer to join our team. As a key member of our team, you will be responsible for ensuring the validation and qualification of computerized systems for our clients in the Life Sciences industry.
About Valspec
Valspec is a trusted partner for clients in the Life Sciences industry, providing commissioning and qualification of computerized systems. Our mission is to provide a wide spectrum of services that help our clients meet their capital project and lifecycle maintenance goals.
Responsibilities
- Support the execution of small projects or portions of larger projects.
- Develop and execute qualification protocols and final summary reports.
- Conduct risk assessments and participate in Quality/Regulatory audits.
- Support the generation of quality assurance plans, verification plans, and validation plans.
Requirements
- 3+ years of Computer System Validation (CSV) experience with process control, SCADA, and automation systems.
- Manufacturing Execution System (MES) experience.
- Experience with automation, commissioning, qualification, or operations in a cGMP environment.
- Direct experience developing validation protocols and executing protocols.
- Knowledge of current industry standards such as GAMP5 and ASTM E2500.
Preferred Skills
- Exposure to Kneat or ValGenesis.
What We Offer
Valspec offers a competitive benefits package, including premium medical, 401K match, profit sharing, tuition reimbursement, and other unique incentives. We are an Equal Opportunity Employer and welcome applications from qualified candidates.
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