- The CSV Engineer will be responsible for delivery of Automation and IT scope on one or more projects in the portfolio of capital projects.
- This candidate will be required to work closely with the teams responsible for the full Automation and IT scope and with vendors / partners with responsibility for delivery of systems.
Core Duties and Responsibilities:
- Partner with local project teams to deliver Automation and IT aspects of capital projects
- Liaise with site AIT group to add input to site SOP’s
- Author\Review\Approval of qualification lifecycle documents for process\lab systems – RS, CS, RTM etc…
- Work with site teams on generation of requirement and\or configuration specification, design specifications and test protocol
- Protocol generation, execution and approval
- Maintain Inventory and control upgrades to PLC/SCADA/DCS system
- Generate any automation change control documentation required for introducing new systems or modifying existing systems.
- Generate any risk assessment\variance documentation and interface with above site team to close out same
- Work closely with the QAIT function to ensure compliance with MSD Quality standards.
- Interface with above site teams for deliverables of Enterprise systems as required
- Ensures that SDLC is appropriately applied
Minimum Qualifications and Experience:
- BS in Engineering, Computer Science, or other technical degree.
- 3 or more years of experience in project/automation/IT support in a similar role.
- Familiar with Annex 11/21CFR Part 11 requirements, GAMP 5 and data integrity guidelines
- Excellent facilitation, problem solving, and decision-making skills.
- Excellent understanding of cGMP’s, SDLC methodologies and LEAN/MPS/ Sigma principles
- Proven facilitation, meeting/workshop management, project management and change management skills are essential.
- Excellent written and oral communication skills, as well as strong presentation skills.
- Demonstrated ability to analyze and define business problems, develop business cases, and identify appropriate process and technological solutions is essential
- Experience in PLC/SCADA/DCS systems
If you would like to discuss this vacancy or to discuss your career and other job opportunities in confidence, contact us:
Please note, we do not require agency assistance with this role.