Validation Engineer with CSV / CQV

Arthur Lawrence
Cambridge, MA, United States
17 days ago
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Role details

Contract type
Permanent contract
Employment type
Full-time (> 32 hours)
Experience level
Starter
Working hours
Regular working hours
Job source

Tech stack

Data Integrity System Testing Iq/oq/pq

Requirements

  • Experience performing validation and calibration activities for pharmaceutical manufacturing and sterile processing equipment in compliance with GMP and 21 CFR Part 11 requirements.
  • Hands-on experience supporting Master Validation Plans (MVPs), SOPs, validation protocols, and Process Performance Qualification (PPQ) activities.
  • Experience executing Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for manufacturing equipment.

Nice to Have Skills:

  • Experience with FDA regulations, data integrity, and computerized system validation (CSV).
  • Familiarity with risk assessments, deviation investigations, CAPA, and change control processes.

About the company

Arthur Lawrence is a management and technology consulting firm providing enterprise-wide business transformation and business applications implementation services to Fortune 100 and Big 4 organizations. Our in-depth technical knowledge and broad experience in working with world-class companies enable organizations to leverage our capabilities in developing winning strategies and cost-effective solutions. We are a UN Women Empowerment Principal Signatory and are certified by National Minority Supplier Development Council.

Recent Associations & Acknowledgments:

  • Been recognized as a 2023 TOP WORKPLACE by the Houston Chronicle
  • IAOP Award; Ranked in the top 100 internationally
  • Ranked among the Inc 5000 twice - as one of the FASTEST GROWING COMPANIES OF AMERICA
  • Member of HMSDC, NMSDC and NY&NJMSDC

Our Seven Pillars:

We rely on the seven core values that we believe enable us to deliver quality for our consultants and clients: Education, Integrity, Value Creation, Collaboration, Best Client, Best People, and Stewardship. Through strict adherence to these core values, we have achieved success beyond all documented forecasts and anticipation.

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