Senior Validation Engineer

Job Title: Computer System Validation Engineer

Location: Thousand Oaks CA

Duration: 12 Months

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 a Amgen Ohio's computer systems validation.

Top 3 Must Have Skill Sets:

1. Experience with ALM or Kneat testing tool is plus.

2. Experience with ServiceNow (Problem, Change management), Track wise (Change Management), Veeva (Document management, CAPA, Deviations, Change Management).

3. Knowledge of cGMP regulations and guidelines including but not limited to U.S. code of Federal Regulations 21 CFR Part 11 and Part 211.

4. Understanding of industry standards and best practices for computer system validation such as GAMP 5.

5. Perform Deviations, CAPA, Change records for Technology computer systems (E.g: MES, SCADA, ASRS, ServiceNow, QBAS, SAP/ERP, Serialization, etc).

1. Perform Deviations, CAPA, Change records for Technology computer systems (E.g: MES, SCADA, ASRS, ServiceNow, QBAS, SAP/ERP, Serialization, etc).

2. Provide support to system owners on completion of Design Specifications, URS, Traceability, IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification) draft copies.

3. Provide support to complete the 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. Perform system periodic reviews for Computerized systems, Automation systems.

7. Familiar with validating SCADA, MES, PI Factory Talk Historian, Serialization systems.

8. Ensures that systems are maintained in a compliant manner according to the Technology quality systems standards.

9. Support regulatory inspections and internal audits as required.

Academic/Technical Qualifications:

1. Bachelor’s Degree in a science or Engineering discipline required.

2. 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

Doctorate degree or Master degree and 3 years of experience or Bachelor degree and 5 years of experience or Associate degree and 10 years of experience or high school diploma / GED and 12 years of experience