A Medical Device client in San Diego, CA is currently looking for a Validation Engineer II and III to work on a 12-24 months contract with the possibility of extension/Direct hire. The selected person will be working an 8 am- 5 pm Monday to Friday work schedule.
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.
Service Delivery 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 Abbott 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
BASIC QUALIFICATIONS | EDUCATION: Bachelors’ degree (B.S.) in a Science related field (Engineering, Biology, Chemistry or equivalent)
2-10 years of related work experience in a medical device industry with strong technical competency in performing equipment qualification (IQ/OQ/PQ), facility/lab qualification, process validations and excel spreadsheet validations. Proficient understanding of Design Control, Good Documentation Practices (GDP), and current Good Manufacturing Practices (cGMP) Significant experience with application of the FDA regulations and recognized standards (e.g., FDA 21 CFR 820.30, FDA 21 CFR 820.70, FDA 21 CFR Part 11, ISO 13485, ISO 14971, cybersecurity)
PREFERRED QUALIFICATIONS: Experience in validation of In Vitro Diagnostic Lab equipment (e.g., Real- Time PCR System, Freezers, Refrigerators, Environmental Chambers, Incubators) and Thermal Mapping, Computerized System Validation. Experience supporting ISO 13485 inspections and FDA inspections. Experience in a multi-site development environment. Experience in compliance management within a rapid-growth, dynamic organization. Statistical or Lean Six Sigma background Working experience with GAMP5 and FDA’s Computer Software Assurance initiatives Working experience with Agile, Maximo and ViewLinc.
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