Engineer Senior IT Business Automation Systems Validation JP13827
Engineer Senior IT Business Automation Systems Validation JP13827
Posted on :
07-04-2025
Employer Active
1 Vacancy
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Share
Send me jobs like this
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Job Description
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 computerrelated 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 followthrough 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 clients Ohios 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:
Bachelors or Masters 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 Inperson
We invite qualified candidates to send your resume to If you decide that youre not interested in pursuing this particular position please feel free to take a look at the other positions on our website www.3keyconsulting/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.
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 computerrelated 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 followthrough 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 clients Ohios 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:
Bachelors or Masters 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 Inperson
We invite qualified candidates to send your resume to If you decide that youre not interested in pursuing this particular position please feel free to take a look at the other positions on our website www.3keyconsulting/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.
Regards
3KC Talent Acquisition Team
Employment Type
Hourly
Key Skills
Report This Job
Disclaimer: Drjobpro.com is only a platform that connects job seekers and employers. Applicants are advised to conduct their own independent research into the credentials of the prospective employer.We always make certain that our clients do not endorse any request for money payments, thus we advise against sharing any personal or bank-related information with any third party. If you suspect fraud or malpractice, please contact us via contact us page.
