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Validation Engineer

2 months ago

Providence, Rhode Island, United States Trinity Consultants - Advent Engineering Full time

CQV Engineer

Location: Boston/Rhode Island

Key Responsibilities:

  • Develop and execute Quality System documentation aimed at promoting effective validation practices within the organization.
  • Create User Requirement Specifications (URS), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols, ensuring adherence to Good Documentation Practices (GDP) and internal quality standards.
  • Formulate validation strategies, supported by relevant statistical analyses, oversee all validation activities, evaluate and compile results, and prepare validation reports.
  • Contribute insights on user and functional requirements for current and future processing equipment, drafting necessary documentation. Collaborate with Contract Manufacturers to guarantee all pertinent user and functional requirements are fulfilled.
  • Assist non-engineering personnel, including R&D and Manufacturing teams, to facilitate successful technology transfer and ongoing enhancements.
  • Complete assigned tasks punctually and proactively communicate any delays or issues to the validation manager and other relevant parties.
  • Adhere to all regulatory, corporate, and Quality System policies.

Qualifications:

  • Bachelor's or Master's degree in engineering or a related field.
  • At least 5 years of experience in a medical device setting or other FDA-regulated environments, with a preference for experience in device-biologic combination products.
  • Familiarity with Design Documentation (URS, FRS, DS, and other engineering specifications), Validation (IQ, OQ, PQ, PV, CSV, MVP, etc.), and Quality Systems (Change Control, Non-Conformances, Requalification, etc.).
  • Comprehensive understanding of the Computer Systems Validation lifecycle and associated documentation.
  • Proficient in Microsoft Office Suite, including Word, Excel, and PowerPoint.
  • Ability to work independently with minimal supervision, manage multiple projects concurrently, and demonstrate strong organizational skills.
  • Excellent communication, interpersonal, and teamwork abilities.
  • Strong technical writing and presentation skills are essential.