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Validation Engineer
2 months ago
CSV Engineer
Location: Boston/Rhode Island
Key Responsibilities:
- Develop and implement Quality System documentation 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 adherence to Good Documentation Practices (GDP) and internal quality standards.
- Draft and establish 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, coordinate all validation activities, evaluate results, and prepare comprehensive validation reports.
- Contribute insights on user and functional requirements for current and future processing equipment, drafting necessary documentation. Collaborate with Contract Manufacturers to ensure all pertinent user and functional requirements are satisfied.
- Assist non-engineering personnel, including those from Research & Development and Manufacturing, to facilitate successful technology transfer and ongoing improvement initiatives.
- Complete assigned tasks punctually and proactively communicate any delays or issues to the validation manager and other relevant 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 experience in device-biologic combination products being highly advantageous.
- 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) principles and knowledge of ISO 13485, ISO 14971, and 21 CFR 820.
- Experience with 21 CFR Part 11 and Data Integrity principles.
- Understanding of GAMP 4 and GAMP 5 categorization and their respective deliverables throughout the Computer Systems Validation lifecycle.
- Proficient in Microsoft Office Suite, including Word, Excel, and PowerPoint.
- Ability to work independently with minimal supervision, manage multiple projects simultaneously, and demonstrate strong communication, interpersonal, and teamwork skills.
- Strong technical writing and presentation skills are essential.
