Automation OEM Engineer

Job Description
Reporting to the Digital Project Lead, this role is specifically responsible for the OEM and associated CSV scope. The position requires close collaboration with Digital teams responsible for Automation and IT, as well as with vendors/partners delivering PLC/SCADA elements of OEM systems.

Key Responsibilities

• Partner with site project teams to scope changes on PLC systems.
• Maintain inventory and manage upgrades to PLC/SCADA systems.
• Follow the SDLC procedure to implement changes, including requirements specification updates, change control, implementation, and testing.

• Perform SDLC-related tasks including, but not limited to:

• Preparing and approving quality assurance plans and close-out reports.

• Partnering with site teams to scope changes and prepare relevant documentation.
• Generating, executing, and approving test protocols.
• Reviewing and approving automation documentation.

• Supporting field equipment testing and commissioning activities.

• Ensure all implementations follow safety and quality standards.

• Use and update development systems as required.
• Educate site project teams on automation standards related to technology selection, system configuration, SDLC, validation, hardware, software environments, and business processes.
• Ensure appropriate service-level agreements (SLAs) are in place for OEM systems, including adequate back-up support.
• Build and maintain relationships with key OEM vendors to ensure reliable supply and cost-effective support models.
• Collaborate with internal IT departments to ensure standard, secure implementations in alignment with corporate standards.

Required Qualifications And Skills

• Bachelor's degree in Engineering, Computer Science, or related technical field.
• Formal training in PLC standards and batch systems.
• 3+ years of experience in PLC applications.
• Proven competence in business analysis for small projects.
• Excellent understanding of cGMPs, SDLC methodologies, and LEAN/MPS/Six Sigma principles.
• Strong facilitation, problem-solving, and decision-making skills.
• Demonstrated ability to analyse and define business problems, develop business cases, and identify appropriate process or technology solutions.

Preferred Skills

• Experience commissioning PLC systems in a GMP manufacturing environment.
• Technical leadership experience.
• Project management experience.
• People management experience.
• Experience in the life sciences sector.

• Experience with one or more of the following applications:

• Kneat, Siemens WinCC/S7, Aveva System Platform/Intouch, Aveva (OSI) PI, Microsoft 365, Windows core systems.

• Experience with one or more of the following processes:

• WFI generation & distribution, building management systems, cleaning and sterilization (parts washers & autoclaves), blending and formulation, filling, packaging, and inspection.