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Cleaning Validation Consultant

Intellectt INC
  • NULL, MA
  • $65–$70
  • Instant Apply
1 day ago

Job Description

Cleaning Validation Consultant / Principal Validation Engineer

Location: Milford, MA

Duration: 12-month

Employment Type: Contract (w2)

Job Summary

Seeking an experienced Cleaning Validation Consultant to support cleaning validation, new product introductions, and lifecycle management of manufacturing equipment in a GMP pharmaceutical or biotech environment.

Responsibilities

  • Lead cleaning validation activities and perform risk assessments.

  • Evaluate new product introductions and changes to existing processes.

  • Determine revalidation requirements and develop validation strategies.

  • Prepare and execute validation protocols, reports, deviations, and change controls.

  • Support equipment qualification, including IQ/OQ/PQ.

  • Maintain validated systems and support Stage 3 Continued Process Verification.

  • Collaborate with Engineering, Quality, Manufacturing, and Technical Operations teams.

  • Ensure compliance with GMP, FDA regulations, and validation standards.

Key Requirements

  • Bachelor's degree in Engineering, Life Sciences, Chemistry, or a related field.

  • 7+ years of validation experience in pharmaceutical, biotech, or CDMO environments.

  • Strong hands-on cleaning validation experience in GMP facilities.

  • Experience with risk assessments, NPI, and revalidation decisions.

  • Knowledge of FDA regulations, GMP, change control, and validation lifecycle management.

  • Strong technical writing and cross-functional project management skills.

  • Must have: ASTM E2500, Stage 3 Continued Process Verification, and single-use manufacturing technologies.

Pay Scale
Anticipated hourly pay range: specific range such as ($65/hr to $70/hr).
Benefits
Employees hired into this position are eligible for the following benefits, subject to the applicable plan terms and eligibility requirements:
Health Insurance: Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for paying the full cost of their insurance premiums.
Retirement Benefits: A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided.
Paid Time Off (PTO): No PTO other than that required by applicable state and local laws

Numbers & Facts

LocationNULL, MA
Salary$65–$70

Skills

  • Biologyunmatched
  • Biotech and Pharmaceuticalunmatched
  • Change Controlunmatched
  • Chemistryunmatched
  • Consultingunmatched
  • Cross-Functionalunmatched
  • FDA Requirementsunmatched
  • GMP (Good Manufacturing Practices)unmatched
  • Maintain Complianceunmatched
  • Manufacturing Equipmentunmatched
  • Manufacturing Managementunmatched
  • Manufacturing Operationsunmatched
  • Manufacturing Technologyunmatched
  • Process Validationunmatched
  • Product Lifecycle Managementunmatched
  • Product Testingunmatched
  • Product/Service Launchunmatched
  • Project/Program Managementunmatched
  • Requirements Validation/Verificationunmatched
  • Risk Analysisunmatched
  • Strategic Planningunmatched
  • System Validationunmatched
  • Systems Maintenanceunmatched
  • Technical Operationsunmatched
  • Technical Writingunmatched
  • Validation Planunmatched
  • Writing Skillsunmatched

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