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We are seeking a highly experienced and technically proficient Control Automation Principal Engineer to lead the design, implementation, and optimization of automation systems within our medical device manufacturing operations, and in compliance with regulatory standards (e.g., FDA, GMP). This role requires a blend of deep technical expertise, strategic thinking, and strong leadership to drive innovation, ensure operational excellence, lead cross-functional project teams, and driving digital transformation initiatives.
The Principal I, Automation & Control Engineering, is primarily responsible for leading technical projects in the design, development, and maintenance of instrument/electrical and automation control systems. You will apply mathematical modeling, analyze dynamic behavior, and use control theory to ensure optimal system performance.
In this role, a typical day will include:
- Lead the development, integration, and lifecycle management of automation and control systems (PLC, SCADA, DCS) in GMP-regulated environments.
- Oversee automation projects from concept through commissioning, ensuring alignment with quality and compliance standards.
- Act as technical liaison with global engineering teams and external vendors to ensure seamless implementation of smart technologies (i.e. auto inspection system, etc.)
- Collaborate with cross-functional teams including Quality Assurance, Validation, IT, and Manufacturing to ensure seamless system integration.
- Ensure all automation systems meet regulatory requirements (21 CFR Part 11, GAMP 5, Data Integrity).
- Lead investigations and root cause analysis for automation-related deviations and implement corrective actions.
- Evaluate and implement new technologies (e.g., PAT, IIoT, digital twins) to support continuous improvement and Pharma 4.0 initiatives.
- Develop and maintain SOPs, validation protocols, and technical documentation.
- Mentor and guide junior engineers and technicians in automation best practices.
WHAT YOU’LL BRING TO ALCON:
- Bachelor’s or Master’s degree in Electrical Engineering, Automation, Mechatronics, or related field.
- Minimum 10 years of experience in automation engineering, with at least 5 years in the pharmaceutical or life sciences industry.
- Deep knowledge of PLCs (e.g., Siemens, Allen-Bradley), SCADA/HMI systems, and industrial communication protocols.
- Strong understanding of GMP, GAMP 5, 21 CFR Part 11, and data integrity principles.
- Proven track record of leading complex automation projects in regulated environments.
Preferred Qualifications:
- PMP or equivalent project management certification.
- Experience with MES, batch control (ISA-88), and data historians (e.g., OSIsoft PI).
- Familiarity with cybersecurity standards for control systems (ISA/IEC 62443).
- Experience with validation and qualification of automation systems (IQ/OQ/PQ).
Leadership & Soft Skills:
- Demonstrated leadership in cross-functional project teams.
- Strong communication and stakeholder management skills.
- Ability to influence and drive change across departments.
- Strategic mindset with a hands-on approach to problem-solving.
HOW YOU CAN THRIVE AT ALCON:
- Good team player
- Part of growing company
- Opportunity be involved and exposure to projects from global site
If you're passionate about automation, compliance, and innovation in medical device manufacturing, we'd love to hear from you. Apply now to be part of a forward-thinking team driving excellence in medical device industry!
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