BS degree in Engineering, Chemistry or other appropriate Scientific or Pharmaceutical discipline.
At least 7 years of demonstrated experience in cGMP automation/computerized systems, quality and compliance areas in the pharmaceutical industry
Thorough understanding of industry standards and best practices for computer system validation such as GAMP 5 and ASTM E2500
Experience with the 21 CFR Part 11 cGMP requirements for electronic records, electronic signatures, system validation strategies and documentation; EU Annex 11 and JP 11
Experience with process controls equipment including PLCs, BMS, Batch, HMIs, SCADA systems, SQL relational database systems and Network Hubs including design and debugging skills in a pharmaceutical or related industry
Experience in technical writing, report generation of testing methodologies of automated systems.
Knowledge of appropriate standards associated with CAPA.
Experience in leading validation project team to ensure final product complies with regulatory agency validation requirements, internal company standards, and current industry practices
Expertise in developing the validation protocols and summary reports for CIQ and COQs
Strong understanding of Testing Life Cycle, Software Development Life Cycle, & QA methodologies
Successful project management as measured in terms of scope, schedule and cost attainment and effective coordination and communications with stakeholders
Record of providing compliant computerized system validation solutions
Effectively contribute to the successful achievement of safety, quality and production goals and metrics through excellent technical process support and problem solving
GSK is a science-led healthcare company. Our mission is to improve the quality of human life by enabling people to do more, feel better and live longer. As the world's largest manufacturer of over-the-counter products, reaching more than 1 billion consumers, GSK's Consumer Healthcare business is on an exciting journey. We're passionate about building the world's best fast-moving consumer healthcare company with a focus on quality, backed by science.
Preventing and treating disease is challenging and inspiring work. At GSK, we support, develop and reward the people who make up our talented workforce. Our Consumer Healthcare facility in Lincoln, Neb., proudly manufactures household names such as Theraflu, Excedrin, Benefiber and Prevacid. We're proud of our heritage and success in the Lincoln area ... and our impact on patients' lives around the world.
The Sr Automation CSV Engineer works in partnership with the Consumer manufacturing site to prepare, review and approve CSV protocols, reports and procedures for GMP controls and computerized systems; provide technical expertise and management on projects and in the review and approval of change control and audit all CSV documentation for compliance with current corporate, FDA and regulatory requirements.
This position is accountable for the lifecycle project scope for GMP automation systems starting with project initiation and continuing through the project phases of planning, design, procurement, construction, commissioning, and control system qualification.
The Senior Automation Computer System Validation (CSV) Engineer will provide technical leadership and accountability for computer system validation engineering standards and computer systems validation for all site manufacturing related automation systems. In this position, the Senior Automation Computer System Validation (CSV) Engineer is responsible for ensuring the successful delivery and maintenance of a compliant and reliable Pharmaceutical Quality System of the automation systems.
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A little about us:
We are a science-led global healthcare company on a mission to help people to do more, feel better and live longer.