Computerized System Validation Engineer
The primary responsibility is to support the qualification of GxP systems across GMS Rockville manufacturing and laboratory areas. Assure the validation program is compliant with global, site and industry practices. Specifically, this role will be responsible for the support of Computerized System Validation at GMS Rockville.
KEY RESPONSIBILITIES: (10 bullet points maximum)
• Supports system computerized system qualification/validation and projects by writing and executing validation protocols ensuring compliance with cGMPs as well as above site policies and procedures.
• Authors final reports summarizing execution validation/qualification protocols and support documents (amendments, repeat test forms, addenda and deviations).
• Interface with Validation, Quality Assurance, Engineering, System Owners and key stakeholders to facilitate timely protocol execution and remediate issues during protocol execution.
• Schedule and coordinate validation activities with system owners and key stakeholders.
• Participate in change control reviews.
• Responsible for continuous improvement of the computerized system validation programs.
• Participates in site computerized system validation projects and initiatives as necessary.
• Trained in self inspections and participate in >25% of department's self Inspections.
Minimum of 3 years of industry- related experience (Computer Science, Validation, Automation/Process Controls or IT) and 1 year or less of hands-on validation experience.
BS/BA in a Computer Science, Scientific, Engineering or computer related discipline
• Familiar with the validation of computerized systems used within biopharmaceutical manufacturing and QC labs
• Understands the requirements of a Biopharma/regulated environment
• Able to communicate effectively with cross-functional teams of diverse people
• Strong planning and program management skills
• Effective organization, communication, presentation and influencing skills.
• Exposure to SAP, QUMAS eDocCompliance, Quality Center ALM, DeltaV, PLCs, Unicorn, Siemens Building Automation System.
At GSK, our mission is to improve the quality of human life by enabling people to do more, feel better and live longer. Our three world-leading businesses research and deliver innovative medicines, vaccines and consumer healthcare products. We need a talented and motivated workforce to deliver against our strategy. To achieve this, we strive to attract the best people and to create an environment that empowers and inspires.
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