What are the responsibilities and job description for the Validation Engineer position at Judge Group, Inc.?
Job Details
Location: New Albany, OH
Salary: $38.00 USD Hourly - $40.00 USD Hourly
Description:
Validation Engineer
100% onsite New Albany OH
6-12-month contract.
The ideal candidate for the Validation Engineer role will have 3-5 years of experience in computerized system validation, deviation management, CAPAs, and change tickets within a GMP-regulated pharmaceutical, biotechnology, or life sciences environment. They must hold a Bachelor's or Master's degree in Computer Science, Information Technology, Management Information Systems, Mechanical Engineering, or a related field, with a Master's degree acceptable only if accompanied by at least 3 years of industry experience (no Entry Level Candidates). The role requires onsite work with limited training time, so candidates must be able to hit the ground running. Overqualified candidates (e.g., PhDs or those with 15 years of experience) may not be the best fit. Strong preference will be given to candidates from a pharmaceutical, biotechnology, or life sciences background.
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.
1. Perform Deviations, CAPA, Change records for DTI computer systems (E.g: MES, SCADA, ASRS, ServiceNow, QBAS, SAP/ERP, Serialization, etc).
2. Provide support to system owners on completing Design Spec, URS, Traceability, IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification) draft copies.
3. Provide support on completion of validation deliverables as required per the project.
4. Develop and execute test scripts in ALM, Kneat test tools to support system owners/IT Application Owners.
5. Ensure and track computer systems periodic reviews and periodic access reviews are completed as per schedule to maintain system maintenance phase.
6. Ensures that systems are maintained in a compliant manner according to the DTI quality systems standards.
7. Support regulatory inspections and internal audits as required.
By providing your phone number, you consent to: (1) receive automated text messages and calls from the Judge Group, Inc. and its affiliates (collectively "Judge") to such phone number regarding job opportunities, your job application, and for other related purposes. Message & data rates apply and message frequency may vary. Consistent with Judge's Privacy Policy, information obtained from your consent will not be shared with third parties for marketing/promotional purposes. Reply STOP to opt out of receiving telephone calls and text messages from Judge and HELP for help.
Contact:
This job and many more are available through The Judge Group. Please apply with us today!
Salary: $38.00 USD Hourly - $40.00 USD Hourly
Description:
Validation Engineer
100% onsite New Albany OH
6-12-month contract.
The ideal candidate for the Validation Engineer role will have 3-5 years of experience in computerized system validation, deviation management, CAPAs, and change tickets within a GMP-regulated pharmaceutical, biotechnology, or life sciences environment. They must hold a Bachelor's or Master's degree in Computer Science, Information Technology, Management Information Systems, Mechanical Engineering, or a related field, with a Master's degree acceptable only if accompanied by at least 3 years of industry experience (no Entry Level Candidates). The role requires onsite work with limited training time, so candidates must be able to hit the ground running. Overqualified candidates (e.g., PhDs or those with 15 years of experience) may not be the best fit. Strong preference will be given to candidates from a pharmaceutical, biotechnology, or life sciences background.
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.
1. Perform Deviations, CAPA, Change records for DTI computer systems (E.g: MES, SCADA, ASRS, ServiceNow, QBAS, SAP/ERP, Serialization, etc).
2. Provide support to system owners on completing Design Spec, URS, Traceability, IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification) draft copies.
3. Provide support on completion of validation deliverables as required per the project.
4. Develop and execute test scripts in ALM, Kneat test tools to support system owners/IT Application Owners.
5. Ensure and track computer systems periodic reviews and periodic access reviews are completed as per schedule to maintain system maintenance phase.
6. Ensures that systems are maintained in a compliant manner according to the DTI quality systems standards.
7. Support regulatory inspections and internal audits as required.
By providing your phone number, you consent to: (1) receive automated text messages and calls from the Judge Group, Inc. and its affiliates (collectively "Judge") to such phone number regarding job opportunities, your job application, and for other related purposes. Message & data rates apply and message frequency may vary. Consistent with Judge's Privacy Policy, information obtained from your consent will not be shared with third parties for marketing/promotional purposes. Reply STOP to opt out of receiving telephone calls and text messages from Judge and HELP for help.
Contact:
This job and many more are available through The Judge Group. Please apply with us today!
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
Salary : $38 - $40
