Manager, Automation Engineering- Onsite

Role Summary

We are seeking a result driven Manager- Automation and Controls to lead site Automation team within our pharmaceutical operation reporting into Digital Systems organization. This role is responsible for leading the design, implementation, maintenance and optimization of control systems and automation technologies across the facility.

Responsibilities

• Support a Safe working environment by aligning with all pertinent environmental health, safety & maintenance program practices, rules, and regulations.
• Collaborate with cross-functional teams including Operations, Quality, IT and Maintenance.
• Manage and supports control system including standalone Manufacturing equipment, systems upgrades, data migrations for DCS, PLC‚Äôs, SCADA, and Data Historian systems.
• Ensure all automation systems comply with regulatory requirements (FDA, cGMP, etc.).
• Mitigates risk within functions through sound design, early risk assessments and implementation of fallback strategies.
• Recommend and implement business strategies and engineering controls to reduce costs, increase efficiency, and drive world-class performance.
• Develop and manage staff through hiring, managing performance, developing talent and providing clear expectations.
• Provide technical leadership for Day-to-day operational shift support for Upstream and Downstream Drug Substance manufacturing.
• Oversee troubleshooting, upgrades and lifecycle planning of automation systems.
• Maintain documentation including functional specification, validation protocols and change controls.
• Experience in change control, nonconformance, corrective & preventative actions, and Commissioning & Qualification activities.
• Work with vendors and contractors for automation related projects and support.
• Lead and support Capital projects. This role involves the application of advanced automation engineering principles in the design, specification, construction, startup, commissioning and qualification of process equipment and systems for capital projects of significant scope and complexity. Demonstrated understanding of project life cycles is preferred.
• Executive presence & communicate complex automation topics in the simplest business language at various partner forums in the workplace.
• As a System SME, be accountable and responsible to provide the necessary support during the internal and external regulatory audits.

Qualifications

• Bachelor‚Äôs degree in computer science or related discipline with a minimum of twelve (12) years of relevant experience required. Master‚Äôs degree in computer science, Engineering, or related discipline with a minimum of ten (10) years of relevant experience required.
• 10+ years‚Äô experience developing and maintaining automation software and equipment and PLC systems in a manufacturing environment; AI and machine learning experience.
• Working experience administering and/or configuring of Distributed Control Systems (DCS) such as Emerson DeltaV, Foxboro I/A, OSI PI, Rockwell PLC are required.
• Direct experience with system development and validation, including development of system specifications (DS, FS, URS) and risk-based validation strategies, and validation protocol development and execution.
• Demonstrated knowledge of 21 CFR Part 11, ISA, Data Integrity requirements for automated systems in the pharmaceutical industry.
• Some familiarity with Industry 4.0 technologies and digital transformation.