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Validation Engineer
2 months ago
CQV Engineer
Location: Boston/Rhode Island
Key Responsibilities:
- Develop and implement documentation for Quality Systems 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 tasks, 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 that 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.
- Carry out assigned responsibilities punctually, proactively communicating any delays or issues to the validation manager and other pertinent stakeholders.
- Adhere to all regulatory, corporate, and Quality System policies.
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. Experience with device-biologic combination products is highly preferred.
- 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.).
- Familiarity with 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 abilities.
- A solid grasp of technical writing and presentation skills is essential.