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Job Title: Engineer Senior, IT Business & Automation Systems Validation (JP13827)
Location: New Albany, OH. 43054
Business Unit: Ops DTI
Employment Type: Contract
Duration: 1+ year with likely extensions and/or conversion to a permanent position.
Rate: $50 - $60/hour W2 DOE with Benefits
Posting Date: 04/04/2025.
Notes: Only qualified candidates need apply.
3 Key Consulting is hiring! We are recruiting an Engineer Senior, Business & Automation Systems Validation for a consulting engagement with our direct client, a leading global biotechnology company.
Job Description:
Primarily responsible for ensuring adherence to computer validation standards and procedures for computer-related systems. Responsibilities include participation in system design, preparation of test protocols, analysis of test results and preparation of summaries. Provides guidance and sets standards in producing quality documentation, serves as the liaison between the IS and Quality functions, provides testing and IT compliance guidance, and provides timely and effective response and follow-through in the resolution of IT Quality/Project compliance issues.
This role is for a strong background in IT Business systems validation, IT Automation systems validation, ensuring that our Information technology systems and processes meet regulatory requirements and industry standards, particularly within the framework of GxP (Good manufacturing Practice) in projects. Integrates a variety of systems technologies to provide systems related solutions to meet business needs. Supports the creation and maintenance of our client's Ohio's computer systems validation.
Perform Deviations, CAPA, Change records for Technology computer systems (E.g: MES, SCADA, ASRS, ServiceNow, QBAS, SAP/ERP, Serialization, etc).
Provide support to system owners on completion of Design Specifications, URS, Traceability, IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification) draft copies.
Provide support to complete the validation deliverables as required per the project.
Develop and execute test scripts in ALM, Kneat test tools to support system owners/IT Application Owners.
Ensure and track computer systems periodic reviews and periodic access reviews are completed as per schedule to maintain system maintenance phase.
Perform system periodic reviews for Computerized systems, Automation systems.
Familiar with validating SCADA, MES, PI Factory Talk Historian, Serialization systems.
Ensures that systems are maintained in a compliant manner according to the Technology quality systems standards.
Support regulatory inspections and internal audits as required.
Top Must Have Skill Sets:
Experience with ALM or Kneat testing tool is plus.
Experience with ServiceNow (Problem, Change management), Track wise (Change Management), Veeva (Document management, CAPA, Deviations, Change Management).
Knowledge of cGMP regulations and guidelines including but not limited to U.S. code of Federal Regulations 21 CFR Part 11 and Part 211.
Understanding of industry standards and best practices for computer system validation such as GAMP 5.
Perform Deviations, CAPA, Change records for Technology computer systems (E.g: MES, SCADA, ASRS, ServiceNow, QBAS, SAP/ERP, Serialization, etc).
Day to Day Responsibilities:
Perform Deviations, CAPA, Change records for Technology computer systems (E.g: MES, SCADA, ASRS, ServiceNow, QBAS, SAP/ERP, Serialization, etc).
Provide support to system owners on completion of Design Spec, URS, Traceability, IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification) draft copies.
Provide support on completion of validation deliverables as required per the project.
Develop and execute test scripts in ALM, Kneat test tools to support system owners/IT Application Owners.
Ensure and track computer systems periodic reviews and periodic access reviews are completed as per schedule to maintain system maintenance phase.
Ensures that systems are maintained in a compliant manner according to the DTI quality systems standards.
Support regulatory inspections and internal audits as required.
Basic Qualifications:
Bachelor's or Master's Degree in a science or Engineering discipline required.
7+ years relevant experience in computer system validation (E.g: MES, SCADA, PI Factory Talk Historian, Building Management system (BMS, QBAS), Serialization, QC systems).
Basic Qualifications
Red Flags:
No experience on computer validation process.
No background from life Sciences/Bio Technology.
No experience on system deviations, CAPA, Change management.
No knowledge on data integrity ALCOA, ALCOA+ principles.
Interview Process:
Webex, or In-person
We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you're not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.