Validation Engineer
2 weeks ago
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 benchmarks.
- Formulate validation strategies, backed by suitable statistical analyses, oversee all validation tasks, evaluate and compile results, and prepare comprehensive validation reports.
- Contribute insights on user and functional requirements for current and upcoming processing equipment, and generate relevant documentation. Collaborate with Contract Manufacturers to ensure all necessary user and functional requirements are fulfilled.
- Assist non-engineering personnel, including R&D and Manufacturing teams, to facilitate successful technology transfer and ongoing improvements.
- Carry out assigned responsibilities punctually and proactively communicate any delays or issues to the validation manager and other pertinent stakeholders.
- Adhere to all regulatory, corporate, and Quality System protocols.
Required 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.
- Proficiency in 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.).
- Solid understanding of the Computer Systems Validation lifecycle and associated documentation.
- Skilled in Microsoft Word, Excel, and PowerPoint.
- Able to work independently with minimal supervision, manage multiple tasks, and support various projects concurrently.
- Exhibit strong communication, interpersonal, and teamwork capabilities.
- A robust understanding of technical writing and presentation skills is essential.
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