We are seeking a highly experienced Lead Automation Engineer to oversee and manage automation projects within our pharmaceutical manufacturing operations. This role involves leading the design, implementation, and validation of automation systems, ensuring they meet GMP standards and regulatory requirements. The ideal candidate will have deep expertise in pharmaceutical manufacturing processes, automation technologies, and the ability to lead cross-functional teams to achieve project goals.
Key Responsibilities:
- Lead the design, development, and implementation of automation systems (e.g., DCS, PLC, SCADA) in pharmaceutical manufacturing environments.
- Oversee automation projects from concept to completion, ensuring they align with production goals, GMP compliance, and regulatory standards (e.g., FDA, EMA).
- Develop and review automation specifications, functional requirements, and design documents.
- Collaborate with process engineers, validation teams, and IT to integrate automation systems with manufacturing operations.
- Lead troubleshooting efforts for automation issues and provide technical support during commissioning and validation phases.
- Ensure that automation systems are validated and compliant with industry standards, including GAMP 5 and 21 CFR Part 11.
- Manage a team of automation engineers and technicians, providing leadership, mentoring, and performance management.
- Maintain automation system documentation, including design change controls, operational manuals, and validation reports.
- Stay updated on the latest industry trends and technologies to continuously improve automation systems and processes.
- Liaise with external vendors and contractors for the procurement, installation, and maintenance of automation systems.
- Ensure that all automation activities comply with company safety policies and procedures.
Qualifications:
- Bachelor's degree in Automation Engineering, Electrical Engineering, or a related field. Advanced degree preferred.
- 8+ years of experience in automation engineering, with a focus on pharmaceutical manufacturing.
- Extensive experience with automation platforms such as DeltaV, Siemens, Allen-Bradley, or Honeywell.
- Strong knowledge of GMP, GAMP 5, 21 CFR Part 11, and other regulatory requirements for pharmaceutical automation.
- Proven track record of managing large-scale automation projects from concept to validation.
- Excellent problem-solving skills and ability to troubleshoot complex automation issues.
- Experience in leading teams and managing cross-functional project teams.
- Strong communication and interpersonal skills to work effectively with internal teams, stakeholders, and external vendors.
- PMP certification or equivalent project management experience is an advantage.
Preferred Skills:
- Knowledge of MES (Manufacturing Execution Systems) and batch processing.
- Experience with data integration, analytics, and IoT technologies in pharmaceutical operations.
- Familiarity with process control systems and system integration for bioprocessing.
