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Valspec · 17 hours ago

Validation Engineer

Indianapolis, IN

Full-time

Onsite

Mid Level

3+ years exp

Valspec is a global provider of system validation and lifecycle services in the Life Sciences industry. The Validation Engineer role involves supporting project execution, generating quality assurance and validation plans, and conducting risk assessments.

Software

Growth Opportunities

No H1B

Responsibilities

Supports the execution of small projects or portions of larger projects

Supports the generation of quality assurance plans, verification plans, validation plans, and standard operating procedures as well as conduct risks assessments and participate in Quality/Regulatory audits

Develops and executes qualification protocols and final summary reports and may participate in commissioning activities

Qualification

Computer System ValidationAutomation SystemsGAMP5 KnowledgeCGMP Environment ExperienceValidation Protocol DevelopmentClient Communication SkillsTactical Thinking

Required

3+ years of Computer System Validation (CSV) experience with process control, SCADA and automation systems, MES and data integration systems (Emerson DeltaV and/or Syncade experience is highly preferred)

Experience with automation, commissioning, qualification or operations in a cGMP environment

Direct experience developing validation protocols and execution of protocols

Knowledge of current industry standards such as GAMP5 and ASTM E2500

Tactical thinker with experience working with customers developing testing, validation and/or quality strategies

Excellent client communication skills