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Validation Engineer
2 months ago
CSV Engineer
Location: Boston/Rhode Island
Key Responsibilities:
- Develop and execute 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 GDP guidelines and internal quality standards.
- Draft and implement Standard Operating Procedures (SOP) and Validation Master Plans (VMP) for the validation of computer systems used in manufacturing.
- Design validation strategies, supported by relevant statistical analyses, and oversee all validation activities, compiling results and drafting comprehensive validation reports.
- Provide insights on user and functional requirements for current and future processing equipment, ensuring all necessary documentation is prepared. Collaborate with Contract Manufacturers to meet all relevant requirements.
- Assist non-engineering personnel, including those in R&D and Manufacturing, to facilitate successful technology transfer 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 environment or other FDA-regulated settings, 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 c.G.x.P principles and knowledge of ISO 13485, ISO 14971, and 21C.F.R.820.
- Experience with 21 CFR Part 11 and Data Integrity requirements.
- Working knowledge of GAMP 4 and GAMP 5 categorization and their respective deliverables for 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.
