JOB PURPOSE
The purpose of this role is to lead the automation and execution within a sterile manufacturing environment, driving digital transformation and operational excellence. The individual will be responsible for maintaining automation systems that ensure process reliability, data integrity, and compliance with global regulatory standards (e.g. cGMP, 21 CFR Part 11).
This role will focus on:
- Automation lifecycle management for manufacturing and critical System systems, including SCADA, PLCs, and MES integration.
- Continuous improvement and digitalization initiatives, leveraging Industry 4.0 technologies such as IoT, predictive analytics, and advanced process control.
- Cybersecurity and data integrity compliance for all automation platforms.
- Project involvement for automation upgrades, expansions, and technology transfers.
- Cross-functional collaboration with Engineering, MS&T, Quality, and Operations to ensure seamless integration of automation solutions into manufacturing processes.
The Automation Lead will also serve as a technical SME, building internal capability for troubleshooting, system optimization, and long-term reliability.
KEY RESPONSIBILITIES
Automation System Ownership
- Serve as system owner for plant automation platforms (PLC, SCADA, MES, historian systems).
- Ensure compliance with data integrity, cybersecurity, and regulatory requirements.
- Maintain validated state of automation systems per GAMP 5 and cGMP guidelines.
Design & Implementation
- Develop and implement automation solutions for new and existing processes, including integration with digital manufacturing systems.
- SME and review URS, FS, SDS, HDS, and validation documentation.
- Involve or lead FAT, SAT, IQ/OQ/PQ activities for related automation projects.
Continuous Improvement & Digitalization
- Drive Industry 4.0 initiatives: predictive maintenance, real-time analytics, and smart sensors.
- Apply Lean and Six Sigma methodologies to optimize automated processes and reduce downtime.
- Implement alarm management best practices and advanced process control strategies.
Project Management
- Manage automation related projects from concept to execution, including budgeting, scheduling, and vendor management.
- Ensure timely delivery of automation upgrades and expansions aligned with business needs.
Technical Leadership & Training
- Provide technical guidance and mentoring to operations and maintenance teams.
- Develop training programs for automation troubleshooting and system optimization.
Compliance & Governance
- Ensure adherence to 21 CFR Part 11, GAMP 5, and cybersecurity standards.
- Support audits and regulatory inspections related to automation/metrology systems.
QUALIFICATIONS
Education: Bachelor’s in Electrical, Electronics, Mechatronics, Automation, or Control Engineering (Master’s preferred).
- Experience:
- 7+ years in automation engineering within pharma/medical device manufacturing.
- Strong knowledge of PLC, SCADA, MES, historian systems
- Experience with data integrity compliance, cybersecurity, and GAMP 5 validation.
- Exposure to digitalization projects, predictive analytics, and Industry 4.0 technologies.
- Certifications (Preferred): ISA Certified Automation Professional (CAP), Six Sigma Green/Black Belt, PMP.
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