Validation Engineer

Validation Engineer-Contract

DO WORK THAT MATTERS

Client Rapid Diagnostics (formerly Alere) is part of Client's Diagnostics family of businesses, bringing together exceptional teams of experts and industry-leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions. At Client, diverse ideas, perspectives, and expertise allow us to create life-changing solutions that help people live healthier lives. In 150 countries and with businesses spanning nutrition, diagnostics, medical devices, and branded generic pharmaceuticals, Client offers you enormous opportunities to explore your interests and help you achieve your career and personal goals.

Client is looking for an outstanding Validation Engineer-Contractor who will effectively lead quality related validation activities to support the Quality Management System. The end goal is to deliver consistent and high-quality validation and supporting documentation for design and development organization. This role requires strong technical, communication, interpersonal and organizational skills, and a solid understanding of the application of FDA, ISO 13485, ISO 14971 standards and company strategies.

This opportunity is available with Infectious Disease Developed Markets (IDDM) Business unit within Client, at our location in Towne Centre San Diego, CA.

Write procedures, investigations, protocols, deviations, CAPA's, reports, change controls, etc. to support ARDx Towne Centre site departments. Perform and document investigations related to validation activities and performs risk assessments of equipment, processes and systems to determine the scope of validation efforts. Generates validation documentation as required (URS, FRS, DRS, FAT, DQ, engineering studies, IOQ, PQ, PV) for cleaning, shipping, sterilization, facilities, utilities, systems, equipment qualification/requalification, computer system validation, spreadsheets, test method validation and process validation.

Writes and/or revises IQ, OQ, PQ related documents, including any or all of the following: SOP's, validation master plans, guidelines and execution plans, automation test plans and technical documents. Responsible for writing Standard Operating Procedures related to Validations and responsible for training Quality Assurance and R&D personal in the validation processes.

Performs on site or support work, including but not limited to:
Validation protocol executions for FAT/SAT/IQ/OQ/PQ/PV. Equipment Qualification test execution. Investigations and deviations. Provides gap analysis, risk management, risk assessment, risk analysis and validation strategy. Data integrity assessments and review of client data Executes protocols and resolves deviations/discrepancies, analyzes data and writes reports. Performing and supervising thermal mapping of temperature-controlled units, Laboratories, warehouses, etc. Ensures that validations are documented using Good Documentation Practices and are in compliance to FDA, ISO 13485, and Client Policies and Procedures.

Evaluate impact on legacy qualifications/validations and determines the scope of re-validation. Support the continuous improvement to the Quality Management System, with a specialty focus on validation processes. Responsible for maintaining a Site Master Validation Plan and ensuring that critical Performance Qualification and/or Process Validations are performed per established schedule. Identify and propose remediation for existing and potential validation issues; provide technical expertise and provide solutions to maintain compliance.

Assist with internal and external audits. Manages validation metrics. Manages change control for validation deliverables in the electronic documentation management system. Participate in multiple, concurrent projects. Develops timelines and tracks project status on assigned projects. Keeps stakeholders informed on the status of important projects. Performs other duties as assigned by Management.

Bachelors' degree (B.S.) in a Science related field (Engineering, Biology,…