Responsible for providing direction for the automation center of excellence group within the Engineering department as it relates to facility and process. Maintain automation systems and related devices in a validated state while continuing to explore and implement continuous improvement technologies. Work hand in hand with the site quality unit to uphold the highest state of compliance with automation systems/devices to support the manufacturing of pharmaceuticals in line with US, EU, Chinese, and Japanese regulations.
ESSENTIAL DUTIES / RESPONSIBILITIES:
• Responsible for overseeing the automation center of excellence:
o Building Automation System (BAS)
o Process PLC/HMI
o Process Automation with recipe design and implementation
o Preventative Maintenance (automation)
o Upgrades and modifications
o Change control
• Ensure BAS is maintained in a constant state of compliance
• Manage change control of automated systems
• Develop/Manage a predictive maintenance approach within automation.
• Collaborate with Information Technology in regards to holistic Automation system infrastructure.
• Support facility infrastructure systems i.e. HVAC, Chilled Water/Steam Systems, USP water, UPS, packaging serialization, etc.
• Partner with automation vendors to design, build, qualify, and maintain state of the art systems
• Network with vendors and technical support to troubleshoot BAS and provide real time solutions.
• Design, assemble, and assign BAS preventative maintenance activities.
Required - Associate’s Degree
Preferred - Bachelor’s Degree
• 7+ years' experience delivering Automation technology within the Pharmaceutical industry.
• Strong background of HVAC systems; Building Automatic Control Systems
• Experienced in PLCs and applicable controls.
• Electrical, Mechanical, HVAC/Refrigeration, and Plumbing back ground.
• Knowledge of applicable regulatory standards (FDA, CFR, OSHA , EPA, etc.)
• Ability to apply engineering principals to resolve issues relating to facility equipment.
• In-depth knowledge of process control systems and automation.
• Advanced knowledge of engineering documentation requirements in a cGMP regulated environment.
• Strong initiative and integrity as well as strong written and verbal communication skills
• Ability to lead varying levels of experienced engineers
• Ability to handle multiple assignments with varying priorities in a manner that meets the company's goals.
• Management of budgetary projects
• An excellent technical (engineering) background, with "hands on" experience.
• Self-driven to meet objectives/goals within the organization.
• Ability to function in both office and field environments