Automation Validation Engineer (5-7 years)
Indianapolis, IN 46285 US
Require/Basic Qualification • BS in Biological/Chemistry, Engineering, Computer Science related technical fields.• Highly motivated individual ready to expand pharmaceutical knowledge with a minimum of 4 years of relevant experience deploying automation in a regulated environment.• Excellent communication skills with the ability to convey information effectively.• Ability to multitask and prioritize.• Skilled at problem-solving.• Experience working in a collaborative environment to complete tasks efficiently.• Knowledge with Pharmaceutical or related regulated industries.• Knowledge in GMP laboratory operations, LIMS and ELN.
The Global Quality Laboratories would like to request support for the next 12-18 months to support the Global Lab Automation Team design secure data/process workflows, proof of concept testing, equipment qualification and computer system validation. Activities the role will take part in to develop and implement our automation platform strategy include but are not limited to: • Project qualification and validation planning• Deliverables attributed to proof-of-concept testing/development.• User requirements and testing trace matrix• Hardware design requirements to satisfy process (if applicable)• Define architectural data handling and transfer technologies/solutions• Data / process flow diagrams• Define process execution system requirements and scope• Design Verification includes design qualifications, computer system validation, and system validation.The assumption is that most service support is on- to support design, proof of concept and validation activities