Job Overview:As a Lead Automation Engineer, you will be responsible for designing, implementing, and maintaining automation systems using Delta V within our pharmaceutical manufacturing facilities. You will play a pivotal role in ensuring the reliability and efficiency of our manufacturing processes while adhering to industry-specific regulations and standards.
Key Responsibilities:
- Delta V System Integration:Lead the design, configuration, and integration of Delta V automation systems within the pharmaceutical production environment.
Ensure seamless communication between Delta V systems and other manufacturing equipment and systems. - Control System Design:Develop and implement control strategies to optimize pharmaceutical manufacturing processes.
Collaborate with cross-functional teams to ensure system design meets project requirements and quality standards. - Validation and Compliance:Ensure all automation systems and processes comply with regulatory standards, such as GMP, GAMP, and 21 CFR Part 11.
Lead validation activities, including IQ/OQ/PQ protocols and reports. - Troubleshooting and Maintenance:Proactively identify and resolve automation system issues to minimize downtime.
Perform routine maintenance and calibration of automation equipment. - Documentation:Maintain accurate documentation, including design specifications, standard operating procedures, and change control records.
Create and update documentation for automation systems as needed. - Team Leadership:Lead a team of automation engineers and technicians, providing guidance, training, and support.
Foster a culture of continuous improvement and innovation within the automation team.
Qualifications:
- Bachelor's degree in Electrical Engineering, Automation, or a related field. Master's degree is a plus.
- Minimum of 7 years of experience in automation engineering, with a focus on Delta V.
- Extensive knowledge of pharmaceutical manufacturing processes and associated regulatory requirements.
- Strong programming and configuration skills related to Delta V DCS systems.
- Familiarity with control system hardware and software, PLCs, SCADA systems, and HMI interfaces.
- Excellent problem-solving and troubleshooting abilities.
- Strong communication and leadership skills.
- Ability to work in a regulated, cGMP-compliant environment.
- Experience with project management and leading cross-functional teams
