Validation Engineer

Position Details

• Client:
  Medical Devices Company
• Position Title:
  
  Validation Engineer
• Duration: 06 months (Possible extension)
• Location:
  
  San Diego, CA 92121 (Onsite)
• Pay Range: $30/hr to $35/hr

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.

• 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's 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, Chemistry or equivalent)
• 5+ 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)

• 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…