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 fresh graduates). 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.
Top 3 Must Have Skill Sets:
1. Perform Deviations, CAPA, Change records for IT 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. Experience with ALM or Kneat testing tool is plus.
5. Knowledge of cGMP regulations and guidelines including but not limited to U.S. code of Federal Regulations 21 CFR Part 11 and Part 211.
6. Understanding of industry standards and best practices for computer system validation such as GAMP 5.
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 a Amgen Ohio's computer systems validation.
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.
Basic Qualifications
Master degree or Bachelor degree and 2 years of experience or Associate degree and 6 years of experience or high school diploma / GED and 8 years of experience