As a Digitalization Consultant in the pharmaceutical industry, you will work on exciting projects to support the transformation of business processes and operations in order to improve efficiency, enhance decision making, drive innovation, optimize operational performance, increase productivity, and reduce costs.
You will be responsible for developing digital strategies, processes, and you will provide solution technological use case that support the client business's objectives.
This is a highly collaborative role where you will work closely with cross-functional teams to understand technological capabilities, and develop use case in accordance with business and user requirement.
Responsibilities
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
- Bachelor’s Degree in Chemical/Electrical/Automation/Bio-Engineering, Information Systems, or Computer Science.
- Experience in digital transformation, consulting, or related field
- Expertise of the pharmaceutical industry and regulatory requirements, including supply chain, manufacturing, quality, automation and validation is REQUIRED.
- 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
- Knowledge and experience in manufacturing Automation Systems, MES & Historian, Lab Systems, ERP and IT-OT, Werum Pas-X
- Excellent computer skills, proficient in the use of the following Microsoft tools: Excel, SharePoint, Word, Visio, and PowerPoint.
- Familiarity with Agile methodology
