Recipe Driven Execution Systems Lead

**Responsibilities**:

- Act as a Change Agent for the respective site, representing Execution Systems RDE to all site stakeholders, including Quality, Manufacturing, Process Engineering, Facilities, and EHS&S. This will include building strong relationships with the customer base and helping them set the proper expectations for project delivery.
- Responsible for interfacing with the user community (Process Engineering, Manufacturing, Quality Operations, etc.) to support RDE implementation both prior to project initiation as well as RDE lifecycle. Support includes training of value drivers, integration into design, start-up support, and support from a data analytics perspective utilizing OSI Pi. Ensures that the end user community at the site understand the capabilities and value in the RDE implementation, and collaborates with them to maximize the value from RDE.
- Primary ES Point of Contact for the site stakeholders related to RDE project(s) roadmap, design, configuration, implementation, and qualification.
- Ensures adherence to the global strategy & scope by providing technical direction and support for the design, implementation, and lifecycle management of PCS, MES, PLC and Data systems for RDE implementation projects.
- Interfaces with customer groups on the project to ensure we are designing, executing, and delivering in accordance with Global Engineering procedures and Execution Systems standards.
- Ensures the overall RDE design and implementation for site CAPEX projects meet Engineering, Manufacturing, and Quality requirements and standards for the operation of the plant. Ensures the standards and templates are being used and understood by the site ES team.
- Accountable for site alignment with Global RDE design standards via interfaces with the Standards and Governance lead, and guidance for the RDE project leads at the respective site. Ensures adherence to CSL’s S88/S95 standard during the lifecycle of RDE projects.
- Accountable of CAPEX project design phase to be fully in compliance with the RDE philosophy goals and objectives
- Supports the technical RDE implementation and technical governance to align on and approve global design changes and standards. Interfaces with the global Standards and Governance lead on the process to evaluate and document any changes to existing standards.
- Contributes to the external partner governance of the RDE global library object standards via Library as a Service (LaaS)
- Supports and guides the team responsible for writing and reviewing RDE Execution System documentation as required by projects and ongoing operations.
- Participates in the creation of the Execution System validation strategy together with the Global and Site CSV & Quality representatives.
- Documents and shares knowledge with other site RDE Implementation Leads to enable continuous improvement via global technical governance committee inclusive of engagement with Execution Systems external partners. Seeks opportunities for optimization of the design, implementation, and qualification activities within the Execution System scope.
- Responsible for ensuring understanding of the current Manufacturing processes within the value stream, working in collaboration with the value stream network.
- Responsible for RDE continuous improvement via tracking of past project success and lessons learned to improve future project implementations.

Qualifications:

- Bachelor of Science (or equivalent) in a relevant Engineering or Science discipline. Masters preferred
- Minimum of 5 years' practical leadership experience in the pharmaceutical industry including direct management experience in Manufacturing, Engineering or Execution Systems/Automation; 8 years preferred, with 5 years or more working experience in Execution Systems/Automation design and support
- Considerable knowledge of pharmaceutical (drug substance and drug product)
- manufacturing operations and support functions, including Quality and Process Engineering.
- Specific experience in process automation, MES and batch manufacturing industry standards (ISA S88 &S95).
- Direct experience designing, building, deploying and supporting automation and execution systems in a regulated large-scale process-based manufacturing environment.
- Experience in running site-based shop floor systems in a globally distributed footprint is highly desirable.
- Demonstrated ability to influence at all organizational levels through clear, concise and impactful verbal and written communication skills.
- Ability to build, mentor and grow a high performing and cohesive team.
- Experience in Process Excellence methodology is desirable, but not required.
- Must have demonstrated capability for technical leadership in complex DCS/PCS /Automation projects with integrated MES systems, initial development through validation of the facility
- Must have demonstrated experience in collaborating with site Manufacturing, Quality and Process Engineering personnel in the impl