Validation Engineer IV located in Abbott Park, IL
We are seeking an experienced Validation Engineer to join our team in Abbott Park, IL. As a Validation Engineer IV, you will be responsible for leading quality related validation activities and maintaining the integrity of the Client’s Quality System. You will act as a single point-of-contact to interface with Abbott division customers and develop and manage documentation for engineering studies and commissioning tests. Additionally, you will provide data entry and statistical analysis of data collected during validation activities.Responsibilities:
Lead quality related validation activities to support the Quality Management System.
Act as a single point-of-contact to interface with Client’s division customers.
Develop and manage documentation for engineering studies. Execute ES activities.
Develop and manage documentation for commissioning tests. Execute CT activities as required.
Develop and maintain the validation traceability matrix.
Provide data entry and statistical analysis of data collected during validation activities.
Develop documentation for GMP criticality assessment and coordinate activities.
Interpret validation/user requirements, provide validation strategy in conjunction with division quality and operations organizations, develop and draft validation protocols (i.e. Design Qualification/Installation Qualification/Operational Qualification/Performance Qualification (DQ/IQ/OQ/PQ),) execute validations, and document validation results in final reports.
Ensure that validations are documented using Good Documentation Practices and are in compliance with Medical and Nutritional Agency Regulations, ISO Standards, and Abbott Policies and Procedures.
Perform investigations related to validation activities; perform risk assessments of equipment/processes to support scope of validation; identify/propose remediation for existing/potential issues; provide technical expertise/solutions to maintain compliance; provide quality-related discipline expertise to divisional customers/project teams; consultation direct/contingent project personnel.
Bachelor's degree (B.S.) in a Science related field (Engineering, Biology, Chemistry or other technical degree OR relevant combination of education or experience).
Familiarity with Good Documentation Practices (GDP)and cGMP environment.
The candidate must have 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.
The successful candidate will be able to perform tasks such as planning, scheduling, estimating discipline project costs including writing/updating/reviewing engineering studies/user requirements.
A strong background validating facilities (Clean rooms HVAC/ Environmental Monitoring Program), Utilities (Water Systems), Equipment (Washers Autoclaves Fillers), Automated Process Controls Statistical Sampling Process Monitoring(SPC).
Demonstrated ability completing successful cross-functional projects driving positive compliance outcomes.
The ideal candidate should possess proficiency using Microsoft Word Excel Outlook for reporting email correspondence.
Troubleshooting experience commissioning commercial industrial refrigeration systems HVAC units utilities distribution controls(multiple platforms is a plus).
The ideal candidate has experience temperature/humidity mapping studies/validation facilities storage spaces manufacturing rooms environmental equipment(e.g.,Freezers Refrigerators Humidity Chambers Incubators etc.).
Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.
Equal Opportunity Employer/Veterans/Disabled
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The Company will consider qualified applicants with arrest and conviction records subject to federal contractor requirements and/or security clearance requirements.