Lead Automation Engineer
Description
The Automation SME will be a key member of our interdisciplinary team, responsible
for providing technical expertise and leadership in the design, implementation, and optimization of
automation solutions for biopharmaceutical manufacturing and laboratory operations. The successful
candidate will collaborate closely with cross-functional teams to identify automation needs, develop
innovative solutions, and ensure compliance with regulatory requirements and industry standards.
Key Responsibilities:
- Develop and implement automation strategies aligned with organizational goals and objectives for biopharmaceutical manufacturing and laboratory operations.
- Lead the assessment of automation needs, identify opportunities for process optimization and efficiency improvement, and develop roadmaps for automation initiatives.
- Design, configure, and implement automation systems, including process control systems, robotics, instrumentation, and data acquisition systems, to support biopharmaceutical manufacturing and laboratory operations.
- Collaborate with internal and external stakeholders to ensure seamless integration on automation systems with existing infrastructure and equipment.
- Serve as the subject matter expert on automation technologies and systems, providing guidance and support to cross-functional teams and project stakeholders.
- Lead troubleshooting efforts and provide technical assistance to resolve complex automation issues and optimize system performance.
- Ensure compliance with regulatory requirements (e.g., FDA, EMA, GMP) and industry standards (e.g., ISA-88, ISA-95) for automation systems and processes.
- Develop and implement procedures and protocols for system validation, change control, and documentation in accordance with regulatory guidelines.
- Develop and deliver training programs and workshops to educate personnel on the use of automation systems and technologies.
- Foster a culture of continuous learning and knowledge sharing to build organizational capabilities in automation and technology.
- Lead automation projects from concept to completion, including project planning, budgeting, resource allocation, and timeline management.
- Coordinate with internal and external stakeholders to ensure successful project execution and achievement of project objectives.
Qualifications:
- Bachelor's or Master's degree in Engineering, Computer Science, or related field required; Ph.D.
- Minimum of 5-10 years of experience in automation engineering, with specific expertise in the biopharmaceutical or biotech industry.
- In-depth knowledge of automation technologies, including process control systems, robotics, SCADA systems, and data acquisition systems.
- Strong understanding of regulatory requirements and standards applicable to automation systems in a GMP environment (e.g., FDA 21 CFR Part 11, GAMP).
- Proven track record of successful project management and execution, with the ability to lead cross-functional teams and deliver results on time and within budget.
- Excellent communication skills, with the ability to effectively communicate complex technical concepts to diverse stakeholders at all levels of the organization.