Verification and Validation Technician - 1st Shift 7am-5pm
The Verification and Validation (V&V) Technician is responsible for supporting deployment and maintenance of the eProgesa Blood Establishment Computerized System (BECS) by participating in all aspects of software test activities, including requirement reviews, test methodology design, integration testing, regression testing, and software V&V activities.
The V&V Technician will be responsible for supporting the goals and objectives of the V&V Department by developing and managing V&V project plans, developing and reviewing validation plans, test protocols, test data, and test reports for all IBBI validation efforts. This individual will participate in the development and review of user requirements and will contribute to the design and implementation of testing processes on medical devices. This individual will execute test cases per protocol and document the results; work closely with vendors to facilitate implementation and application of validation principles throughout the user deployment process; and provide technical direction and hands-on assistance for V&V projects. The candidate will recommend process improvements based on the review of existing procedures and protocols
ESSENTIAL JOB FUNCTIONS:
- Complies with prescribed SOPs, cGMPs and applicable regulations.
- Manages all aspects of assigned V&V projects, including, but not limited to, interdepartmental personnel, expenses, and daily V&V schedules.
- Maintains files of the execution of assigned V&V protocols.
- Prepares assigned V&V protocols and reports. Coordinates validation activities through constant communication with affected departments and personnel; oversees and reviews validation processes and procedures.
- Captures, reviews and refines user requirements and determines the scope of testing required.
- Develops test methodologies to verify software, hardware and process requirements.
- Writes clear, concise, detailed and readable test procedure documentation following user, manufacturer, and regulatory guidelines and templates.
- Participates in the execution of software and hardware validation protocols (per IBBI business and compliance goals).
- Monitors the execution of each V&V protocol for compliance with procedures, user specifications, and applicable government regulations.
- Implements and drives continuous improvement activities utilizing the change management process and incorporation of V&V best practices.
OTHER JOB DUTIES:
- Trains interdepartmental teams on basic V&V principles and protocols. (Frequently)
- Interacts internally with Operational, Information Technology, Laboratory, Quality Assurance and Regulatory Affairs personnel.
- Interacts externally with customer and regulatory audit teams, test, instrument and other approved vendors.
- Performs all other duties as required/assigned.
QUALIFICATIONS / EXPERIENCE:
- Bachelors of Science in Computer Science, Quality Engineering, Business Administration or the Biological Sciences, required.
- Must have good interpersonal and communication skills.
- Explicit attention to detail is required.
- Must have excellent organization and follow-up skills.
- Must have excellent problem-solving skills and ability to analyze situations in a timely manner.
- Must have ability to organize and prioritize work assignments.
- Ability and desire to work in a fast-paced team environment.
- Must have ability to participate in multi-functional teams.
- Must have ability to establish and maintain effective working relationships within The Interstate Companies and provide excellent customer service.
- Proficiency with computers.
- Familiarity with Source Plasma Donor Center Operations
- Familiarity with Blood Establishment Computer Systems
- Validation experience in a regulated industry (e.g. FDA 21 CFR 820, the Quality System Regulation, ISO, PPTA, and EU.)
- Experience in software testing, verification, and validation, including regression testing and defect management and tracking.
- Experience in defining test strategy, designing and developing test cases from software requirements, and software architecture designs.
- Experience in writing User Requirements Specifications and Test Traceability Matrices.