Position Summary The Manager of Automation Engineering leads Automation Engineers and contractors responsible for instrumentation and controls of manufacturing equipment, integration of equipment, and site continuous improvement efforts. This includes the design, implementation, and documentation of automation projects and their lifecycle management in compliance with FDA regulations. Represents the department regarding automation issues during regulatory meetings and audits. Managerial duties including hiring, on-the-job training, career development, appraising performance, and motivating their team and peers to perform at their best.Job Responsibilities
- Oversees, manages, and ensures the successful day-to-day operations of the Automation Engineering department.
- Generate, review, approve and control departmental documentation (e.g., SOPs and system reports). Participate in document revisions, providing input, as necessary.
- Support the generation and execution of Validation life cycle documentation such as Systems Commissioning, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Design Qualification (DQ) Validation Summary Reports, and Deviations reports for Manufacturing and process Equipment & Utilities.
- Co-ordinate and execute continuous improvement for key site projects to implement new equipment, technology, processes, or materials
- Manage and execute automation and controls systems for capital investments at the site, as well as develop site procedures for documentation of automation control systems, from specifications through operational procedures.
- Lead Automaton Projects including the definition of the scope of work and specification development. Hands-on ability to develop robust systems and workflows that employ high re-use and require low maintenance.
- Evaluate and recommend automation upgrades to existing equipment or systems. Code and improve existing automated device fabrication and test framework,
- Estimate automation hardware, software, and manpower requirements. Coordinate design and/or manufacturing and software efforts to ensure compliance.
- Manage employee(s) or contractors and coordinate with vendors for work execution. Account for all contractor resources assigned to the project.
- Review and/or draft Equipment Drawings, Electrical Diagrams, System Manuals, Engineering Protocols and Reports, and other Quality System Documentation.
Experience Requirements
- 8+ years of experience with managing and developing automated/mechanical systems. Hands-on experience with machine vision, engineering design, commissioning, and validation. Planning and scheduling experience in these activities is required.
- Leadership Skills: Proven ability to influence others and lead significant change.
- Strong communication skills both written and verbal, including technical writing
- Ability to work on multiple projects simultaneously.
- Proficient in PLC programming
- Proficient in a data historian and manufacturing execution system applications
- Familiarity with SAP
- Familiarity with cGMP standards
- Experience validating manufacturing processes is required. Knowledge and experience in utilizing risk-based approaches to validation process development and validation are highly advantageous.
Education Requirements
- B.S. or M.S. in Mechanical/Electrical engineering or equivalent automation experience in Pharmaceutical/Chemicals/Medical Device industries
EOE, including disability/vets.