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Equipment Validation Engineer

1 month ago

Middletown, United States Kelly Science, Engineering, Technology & Telecom Full time

Equipment Validation Engineer

  • Location: (ONSITE) - Middleton, VA (22645)
  • Duration: 12 months - (Temp to Perm Opportunity)
  • Type: W2 contract (NO C2C OR THIRD PARTY)
  • Shift: 1st shift
  • Pay: Negotiable depending on related direct experience up to $38 an hour
  • Visa sponsorship is not available, now or in the future, for this position.

REQUIRED DEMONSTRATED KNOWLEDGE:

  • Industry standards and regulatory guidelines
  • Applicable mathematics and scientific practices including statistical sampling plans and statistical and data analysis
  • Thorough understanding of related equipment and the ability to perform equipment modifications

Position Summary:

  • The Validation Engineer will be responsible for the execution of project validation master plans and contribute to designing approaches based on risk.

Key Responsibilities:

  • Authors and executes qualifications and validations
  • Analyzes data from validation tests to determine whether systems and processes meet required criteria and specifications
  • Collaborates and coordinates with appropriate departments and staff regarding the scheduling or implementation of validation testing
  • Identifies root causes of production problems associated with validation
  • Identifies nonconformities of product or process standard and offers recommendations for resolving deviations
  • Develops, maintains, or reviews validation and compliance documentation including schematics, protocols, and engineering change notices
  • Modifies testing methods or revisits test objectives and standards to resolve testing problems.
  • Calibrates equipment to ensure accurate measurements.

Minimum Requirements/Qualifications:

  • Bachelor's degree in related field required
  • 1-3 years of experience within the Medical Device or Pharmaceutical Industry supporting the manufacture of Regulated Products
  • Knowledge of validation in a FDA Regulated Environment.
  • Knowledge and understanding of: Quality standards (e.g., 21 CFR Part 820, ISO 13485) & Quality tools (e.g. FMEA, Risk Analysis, Root Cause Analysis) & Computer Systems (e.g. TrackWise, MasterControl, AGILE, SAP)

Preferred

  • Experience supporting a project team responsible for validation
  • Experience supporting mixing and cleaning validations for formulation vessels and fill lines

Work Authorization:

  • Must be able to work in the United States with current employment authorization documents. Visa status that requires sponsorship now or in the future is not allowed for this role. Visa sponsorship is not available, now or in the future, for this position.

Important information: To be immediately considered, please send an updated version of your resume to Deas172@

*** (Kelly does not expense relocation/interview costs)**

In addition to working with the world's most recognized and trusted name in staffing, Kelly employees can expect:

  • Competitive pay
  • Paid holidays
  • Year-end bonus program
  • Recognition and incentive programs
  • Access to continuing education via the Kelly Learning Center