Process Automation Engineering Group Manager - United States
- Our company is a leading global healthcare supplier that develops, manufactures and distributes over-the-counter (OTC) and prescription (Rx) pharmaceuticals, nutritional products, and active pharmaceutical ingredients (API).
- The company is the world's largest manufacturer of OTC pharmaceutical products for the store brand market and an industry leader in pharmaceutical technologies.
- Our company is looking to add a Process Automation Engineering Group (PACG) Manager to our team.
- Process Automation Engineering Group (PACG) Manager provides technical automation and compliance support to infant formula manufacturing and packaging operations.
- Provides leadership to process automation control engineers and instrument technicians to support quality initiatives, improve productivity and costs, find and address root causes for process interruptions.
- Explore innovative and alternate solutions to meet business needs, provides staff with corporate vision and goals, and provides great customer service to Operations to meet and exceed their objectives, through timely, innovative, professional and safe practices.
Duties/Responsibilities include, but not limited to:
- Directs process automation control engineers and hourly technicians, support staff and contracted resources to assure customer expectations are met.
- Provides direction for all process automation activities, and interfaces with department managers and supervisors to remove roadblocks and provide service to meet production schedules. Investigates and resolves control system problems impacting plant reliability or efficiency.
- Works through and resolves network and automation issues to support the manufacturing systems.
- Institutes programs to enhance equipment utilization and increase efficiency on work centers. Completes capital and expense projects by meeting agreed upon timelines, scope, and budget, generated with Operations and Engineering, while managing and tracking project costs to complete projects on budget.
- Approves equipment purchases / modifications to enhance operations.
- Supports team during implementation of equipment control systems and design standards [reviews/ evaluates proposed systems to insure compliance with established hardware, software, and design standard(s)] and the implementation of systems built using in-house or contracted resources.
- Facilitates compliance with FDA current Good Manufacturing Practice (cGMP) regulations during the design, specification, qualification, validation, maintenance, and use of equipment control systems. Oversees change management program to evaluate the impact of proposed activities on the validation status of control systems, and supports qualification/re-qualification or validation/re-validation activities to insure the validated status of affected control systems.
- Supports quality initiatives and provides resources for change control, validation, cGMP training and development of engineering standards and good engineering practices.
- Supports the Automated Systems Validation (ASV) program and user requirements to ensure the validated status of control systems are in accordance with FDA regulations and industry standards.
- Maintains proficient engineering services in developing and implementing control system delivery to support manufacturing facility operations. Maintains fundamental working knowledge of cGMP regulations and implements such principles using established corporate policy, procedure, and industry standards.
- Bachelor’s degree in Engineering or related field required. Bachelor’s in Electrical, Automation, or Process Control Engineering preferred. Consideration may be given to those who hold 10 years of progressively responsible and relevant work experience.
- Five years of process control related experience in a production setting at a minimum.
- Prefer five or more years of management experience.
- Must have a minimum of five years of process control related experience in a production setting.
- Previous pharmaceutical or food / dairy industry experience preferred.
- Management of calibration systems is a requirement.
- Experience with computer validation and change management in an FDA/cGMP related environment, including experience and familiarity with Good Automated Manufacturing Practices (GAMP).
- Must have demonstrated experience with Programmable Logic Controllers (PLC) and PC-based supervisory control and data acquisition systems (SCADA) (currently using Allen-Bradley/Rockwell, and experience with GE IFIX is helpful).
- Ability to ensure all control systems meet standards and customer specifications preferred.
- Hands on knowledge of control system applications and hardware components including Human Machine Interface (HMI).
- Experience with Ethernet networks, PC hardware and servers, and associated operating systems and SQL databases.
- Familiarity with Manufacturing Execution Systems (MES), and integration with lower level systems required. Familiarity with Plant Historian systems preferred.
- Experience with vision systems. Familiarity with Cognex, C I Vision, Keyence and Data Logix systems would be ideal.
- Must have a basic understanding of batch control fundamentals and be able to demonstrate the use of standard principles, theories, concepts and techniques.
- Working knowledge of AutoCAD software, and the ability to read, understand, and create drawings, flowcharts, schematics, as it relates to control system design documentation is desirable.
- Demonstrated understanding of Lean and Six Sigma processes preferred, including experience with the different continuous improvement techniques, and the ability to utilize appropriate tools to guide and derive root causes.
- Demonstrated self-confidence, and ability to manage consultants, and contractors, while interfacing with multiple departments, working with internal engineers to manage control system projects, policy and procedures preferred.
- Strong analytical and problem solving skills, and excellent interpersonal skills, including good oral and written communication skills preferred.
- Ability to handle and resolve conflicts and maintain confidentiality required.