SR Automation Engineer

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Wat je gaat doen

The Senior Automation Engineer will lead end‑to‑end automation and digitalization initiatives within a regulated manufacturing environment, driving capital and continuous improvement projects from concept through validation. This role provides technical leadership across system architecture, design, deployment, and troubleshooting of GMP‑compliant automation systems, while ensuring adherence to global standards, data integrity, and regulatory requirements (FDA, EMA, ANVISA). The position supports CAPEX planning, project governance, stakeholder alignment, and cross‑functional collaboration with Quality, Manufacturing, IT, Process Engineering, and Validation. Acting as a subject matter expert in automation and control systems, the engineer will guide multidisciplinary teams, manage vendors, support audits, and foster a culture of continuous improvement, safety, and compliance

Key Responsibilities

• Leads automation projects in a regulated environment using established Project Management methodologies, including project schedules, kickoff meetings, risk and mitigation registers, issue and action logs, change management records, decision logs, and stabilization plans.

• Leads, plans, and executes automation and digitalization activities across manufacturing operations, typically within capital and continuous improvement projects.

• Provides technical leadership and support for automation and digital transformation initiatives, including system architecture, design, development, and deployment of GMP-compliant automation systems.

• Supports Capital Expenditure (CAPEX) projects, manufacturing operations, new product introductions (NPI), technology transfers, and process improvement initiatives, ensuring alignment with site stakeholders and global standards.

• Accountable for project capital planning, monthly and quarterly spend tracking, cash flow forecasting, contingency management, and scope control.

• Develops, reviews, and approves Computerized System Validation (CSV) documentation in compliance with regulatory requirements, including FDA, EMA, and ANVISA guidelines.

• Ensures automation systems comply with GMP, data integrity (ALCOA), and cybersecurity requirements throughout their lifecycle.

• Leads project execution activities across all phases (Concept, Planning, Design, Implementation, Commissioning, Qualification, Validation, and Post-Implementation Support).

• Leads multidisciplinary project teams, including internal engineering resources, external system integrators, vendors, and service providers.

• Provides technical leadership for manufacturing troubleshooting and quality investigations, including deviation investigations, root cause analysis, and CAPA development; supports both immediate corrective actions and long-term preventive solutions.

• Collaborates closely with Quality, Manufacturing, IT, Process Engineering, and Validation teams to ensure compliant and robust automation solutions.

• Acts as a technical subject matter expert (SME) in automation and control systems, supporting audits and regulatory inspections when required.

• Promotes a culture of continuous improvement, knowledge sharing, and adherence to safety and compliance standards.

Required Qualifications

• Bachelor’s degree in electrical engineering, Automation Engineering, or a related engineering discipline

• Minimum of 4 years of experience in industrial automation, preferably within cometic, biotech, or other GMP-regulated industries.

• Proven experience managing large CAPEX projects in regulated manufacturing environments, meeting schedule, cost, and quality requirements.

• Advanced expertise in PLC-based control systems, SCADA, and industrial control systems used in pharmaceutical manufacturing.

• Experience working in environments subject to FDA, EMA, and ANVISA regulatory oversight.

• Intermediate English proficiency, with the ability to communicate effectively in technical and cross-functional settings.

• Experience with Allen-Bradley (Rockwell Automation) and Siemens platforms; familiarity with Aveva solutions (e.g., Wonderware, System Platform, MES) is highly desirable.

• Experience with MES, historian systems, electronic batch records (EBR), and manufacturing data systems is a plus.

Preferred Qualifications

• Project Management certification (PMP, FPX, or equivalent).

• Demonstrated experience leading engineering and automation teams.

• Knowledge of Isolated Computing Environments (ICE networks) commonly used in regulated industries.

• Strong troubleshooting capabilities in complex automation software and integrated manufacturing systems.

• Ability to design, develop, and modify complex shop floor automation and control systems supporting GMP processes.

• Experience with Allen-Bradley (Rockwell Automation) and Siemens platforms; familiarity with Aveva solutions (e.g., Wonderware, System Platform, MES) is highly desirable.

• Experience with MES, historian systems, electronic batch records (EBR), and manufacturing data systems is a plus.

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