Automation Engineering Office (AEO) Digitalization Lead for end-to-end implementation of the following technologies for a brownfield Vaccine Manufacturing Plant
Process Analytical Technology, (2) RTLS, (3) Smart Authentication (Nymi Bands)
- Design Phase Responsibilities with Support from Cognizant SMEs for respective packages
- Responsible for working with Cognizant SMEs to develop the User Requirement Specifications and System Architectures for relevant work packages.
- Review / Prepare the design documentation for each package (includes URS, interface design, data architecture, system architecture, landscape design).
- Present the design in review meetings and obtain feedback. Work closely with stakeholders, EPCM and selected System Integrators to review detail design documents.
Procurement Phase Responsibilities
- Support the procurement activities by preparing tender documentation or SOW documentation and vendor selection.
- Handle vendor technical queries
Execution Phase Responsibilities
- Lead and manage the selected system integrator.
- Leading and driving a system integrator involves overseeing and guiding the integration process of various technologies and systems to achieve a unified and efficient solution.
- Provide clear direction and set objectives, ensuring alignment with the project master schedule.
- Driving the integration involves monitoring progress, resolving conflicts, and making timely decisions to keep the project on track.
- Monitoring performance, managing risks, and ensuring quality delivery..
- Design review, configuration standards, meeting with SI, approval
- Participate in Kick-off meeting by each system integrator.
- Review of Detail Design, layout drawings, data sheets , System architecture drawing, I/O Rack / slot / channel allocation list, Network address list, Interface specifications for 3rd party equipment & systems
- Organize Monthly governance meeting.
- Track Progress report/risk and issue register
Testing / Validation Phase Responsibilities
- Support development of a comprehensive validation plan specially for GMP systems
- Prepare System Risk Assessments
- Help to outline the qualification approach, including installation qualification, operational qualification, and performance qualification, to demonstrate that the system functions as intended and meets regulatory standards.
- Help defining scope for commissioning strategies, protocols, and acceptance criteria to verify that the system meets specified requirements.
- Witness and Sign-off of the IQ, OQ, IOQ
Requirements
- Experience in digital transformation, consulting, or related field
- Expertise of the pharmaceutical industry and regulatory requirements, including supply chain, manufacturing, quality, automation and validation
- Experience in project management and delivering complex projects
- Strong analytical and problem-solving skills
- Excellent communication and interpersonal skills, ability to communicate technical information to non-technical stakeholders
- Ability to work independently and as part of a team
- Possess the drive to do what it takes to deliver results and exceed customer expectations
- Experience with emerging technologies such as artificial intelligence and machine learning
- Excellent computer skills, proficient in the use of the following Microsoft tools: Excel, SharePoint, Word, Visio, and PowerPoint.
- Familiarity with Agile methodology
About Cognizant
Cognizant (NASDAQ-100: CTSH) is one of the world's leading professional services companies, transforming clients' business, operating and technology models for the digital era. Our unique industry-based, consultative approach helps clients envision, build and run more innovative and efficient businesses. Headquartered in the U.S., Cognizant is ranked 195 on the Fortune 500 and is consistently listed among the most admired companies in the world. Learn how Cognizant helps clients lead with digital at www.cognizant.com or follow us @Cognizant.
