Validation Systems Engineer

2 weeks ago


Boston, Massachusetts, United States Trinity Consultants - Advent Engineering Full time

CSV Engineer

Location: Boston/Rhode Island

Key Responsibilities:

  • Develop and implement documentation for Quality Systems aimed at establishing effective validation practices within the organization.
  • Create User Requirement Specifications (URS), Functional Requirement Specifications (FRS), Risk Assessments, Configuration Specifications, Design Specifications, and CSV test protocols, ensuring compliance with Good Documentation Practices (GDP) and internal quality standards.
  • Draft and enhance Standard Operating Procedures (SOP) and Validation Master Plans (VMP) for the validation of computer systems used in manufacturing processes.
  • Design validation strategies supported by relevant statistical analyses, oversee all validation activities, analyze outcomes, and compile validation reports.
  • Contribute insights on user and functional requirements for current and future processing equipment, and prepare necessary documentation. Collaborate with Contract Manufacturers to ensure that all pertinent user and functional requirements are satisfied.
  • Assist non-engineering personnel, including those from Research & Development and Manufacturing, to facilitate successful technology transfers and promote continuous improvement.
  • Complete assigned tasks punctually and proactively communicate any delays or issues to the validation manager and other stakeholders.
  • Adhere to all regulatory, corporate, and Quality System policies.

Qualifications:

  • Bachelor's or Master's degree in engineering or a related field.
  • A minimum of 5 years of experience in a medical device setting or other FDA-regulated environments, with a preference for experience in device-biologic combination products.
  • Proficient in Design Documentation (URS, FRS, CS, DS, and other engineering specifications) and Validation processes (OQ, CSV, etc.).
  • Familiarity with current Good Practices (c.G.x.P) and knowledge of ISO 13485, ISO 14971, and 21 CFR 820.
  • Experience with 21 CFR Part 11 and Data Integrity principles.
  • Working knowledge of GAMP 4 and GAMP 5 categorization and their respective deliverables throughout the Computer Systems Validation lifecycle.
  • Skilled in Microsoft Word, Excel, and PowerPoint.
  • Able to work independently with minimal supervision, manage multiple projects concurrently, and demonstrate strong communication, interpersonal, and teamwork abilities.
  • Exhibit a solid understanding of technical writing and presentation skills.

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