Validation Engineer III

About the role

Abbott is seeking a Validation Engineer-Contractor to lead quality-related validation activities to support the Quality Management System. The role involves delivering consistent and high-quality validation and supporting documentation for design and development organization. Key responsibilities include writing procedures, investigations, protocols, deviations, CAPA's, reports, change controls, and generating validation documentation.

Responsibilities

• 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 perform risk assessments of equipment, processes and systems to determine the scope of validation efforts.
• Generate 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.
• Write and/or revise IQ, OQ, PQ related documents, including 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 personnel in the validation processes.
• Perform 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, providing gap analysis, risk management, risk assessment, risk analysis and validation strategy, data integrity assessments and review of client data, executing protocols and resolving deviations/discrepancies, analyzing data and writing reports, performing and supervising thermal mapping of temperature-controlled units, laboratories, warehouses, etc.
• Ensure validations are documented using Good Documentation Practices and are compliant with FDA, ISO 13485, and Abbott policies and procedures.
• Evaluate impact on legacy qualifications/validations and determine the scope of re-validation.
• Support continuous improvement to the Quality Management System, with a specialty focus on validation processes.
• Maintain a Site Master Validation Plan and ensure 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 solutions to maintain compliance.
• Aid in internal and external audits.
• Manage validation metrics.
• Manage change control for validation deliverables in the electronic documentation management system.
• Manage multiple concurrent projects.
• Develop timelines and track project status on assigned projects.
• Keep stakeholders informed on the status of important projects.
• Perform other duties as assigned by Management.

Qualifications

• Bachelor’s 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.
• 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).

Priorities

• 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.

Competencies

• Good working knowledge of Excel and Microsoft Word software.
• Working knowledge of quality techniques such as root cause analysis, 5 why’s, and Ishikawa diagrams.
• Excellent problem-solving and decision-making skills.
• Self-starting, detail-oriented, and ability to focus on task at hand.
• Initiative to work towards goals with minimal supervision.
• Ability to work independently with multiple departments to resolve Validation issues.
• Must be able to work effectively in a fast-paced, cross-functional team-oriented environment.
• Well-developed English written and verbal communication skills.