Validation Engineer IV
Abbott Park Road Lake Bluff, IL 60044 US
*Depending on experience
Duties: Corporate Engineering is looking for an outstanding Principal Validation Engineer who will effectively lead quality related validation activities to support the Quality Management System. The end goal is to deliver high-quality validation and supporting documentation to Manufacturing Sites and Division Engineering Projects.
• Maintaining the integrity of the Quality System
• Act as a single point-of-contact to interface with division customers
• Develop and manage documentation for engineering studies (“ES”). Execute ES activities.
• Develop and manage documentation for commissioning tests (“CT”). Execute CT activities as required
• Develop and maintain the validation traceability matrix (“VTM”)
• Provide data entry and statistical analysis of data collected during validation activities
• Develop documentation for GMP criticality assessment and coordinate activities
• Interprets validation/user requirements, provides validation strategy in conjunction with division quality and operations organizations, develops and drafts validation protocols [i.e. Design Qualification/Installation Qualification/Operational Qualification/Performance Qualification (DQ/IQ/OQ/PQ),] executes validations and documents validation results in final reports
• Ensures that validations are documented using Good Documentation Practices and in compliance with Medical and Nutritional Agency Regulations, ISO Standards, and Policies and Procedures
• Perform and document investigations related to validation activities and performs risk assessments of equipment and processes to support scope of validation
• Identify and propose remediation for existing and potential validation issues; provide technical expertise and provide solutions to maintain compliance
• Provide quality-related discipline expertise to divisional customers, project teams and consultation to direct and contingent project personnel
• Performs other duties as assigned by Management.
Skills: The successful candidate will be able to perform, plan, schedule and estimate discipline project costs including writing, updating and reviewing of engineering studies, user requirements, validation plans, qualification protocols and reports. Generate, input, route and review items for approval in the quality system.
• 5-10 years of related work experience in a medical device or other healthcare industry with strong technical competency in performing facility/utilities/equipment qualification, et al. validations
• Must be familiar with good documentation practices (GDP) and cGMP environment
• Strong validation experience in the following areas: Facilities (Clean rooms, HVAC/ Environmental Monitoring Program), Utilities (Water Systems), Equipment (Washers, Autoclaves and Fillers), Automated Process Controls, Statistical Sampling and Process Monitoring (SPC)
• Has a history of completing successful cross-functional projects and driving positive, compliance outcomes
• Proficient using Microsoft Word, Excel and Outlook for reporting and email correspondence.
• Experience in temperature/humidity mapping studies and validation of facilities storage spaces and manufacturing rooms, as well as environmental equipment (e.g., Freezers, Refrigerators, Humidity Chambers, Incubators, etc.)
• Experience with troubleshooting and commissioning of commercial and/or industrial refrigeration systems, HVAC units, utilities distribution and controls (multiple platforms is a plus)
Education: Bachelors’ degree (B.S.) in a Science related field (Engineering, Biology, Chemistry, other technical degree OR relevant combination of education or experience). Manager will consider someone with an Associates degree as long as they have the working experience.
• Travel 25%-50% of the time. Mostly domestic, but there could be a small possibility of international travel
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.