Develop and implement a comprehensive operations automation strategy that aligns with the site’s business goals and objectives.
Team Leadership: Manage and mentor a team of automation engineers and build capability and skills with maintenance technicians, fostering a collaborative and innovative work environment.
System Design and Implementation: Lead the design, development, and implementation of advanced automation systems, including PLCs, SCADA, and DCS.
GMP Compliance: Ensure all automation systems and processes comply with Good Manufacturing Practices (GMP) and regulatory requirements.
Training and Development: Develop and deliver training programs to ensure staff are proficient in the use of automation technologies and best practices.
Continuous Improvement: Drive continuous improvement initiatives by staying current with emerging automation technologies and industry trends and integrating them into the site’s operations where applicable.
Technical Support: Provide technical support and troubleshooting for automation systems to minimize downtime and ensure smooth operations.
Provide subject matter expertise to regulatory inspections and interact with auditors as necessary.
Requirements & Skills:
Degree in a Science/Engineering-related discipline such as Automation, Control, Electrical, or Mechatronic.
Six Sigma and Lean Manufacturing experience gained from the pharmaceutical industry.; Black Belt or Green Belt desirable.
Technical expertise in several scientific and engineering automation areas including ISA standards (e.g. S88, S95), P&ID nomenclature, Automation architecture, instrumentation and electrical wiring diagrams, communication networks, control panels, HMI, MES, SCADA, PLC, and Historians.
Broad and in-depth knowledge with practical experience in computer and application validation (preferably using GAMP methodology), cGMPs, and 21 CFR Part 11 in an FDA-regulated environment.
Proven Leadership Skills in a cGMP environment gained from hands-on programming and troubleshooting for Automation, Instrumentation, and IT systems.
Ability to interface with operational and senior management within the organization.
Experience gained designing and programming automation applications. It may include both firmware and software development.
MEng / MSc in a Science or Engineering related discipline such as Automation, Control, Electrical or Mechatronic.
A sound scientific and engineering understanding of pharmaceutical secondary processing.
Good knowledge of IT architecture management, data warehousing, virtualization & implementation processes
Practical knowledge of Cybersecurity within an OT space.
Demonstrated project management skills.
Working knowledge and understanding of EHS Practices and regulations with respect to the installation of automated plants.
A good appreciation of FDA PAT initiatives and their impact on the Pharma industry.
Proven track record in providing automation support and maintenance for instrumentation, automation, and controls.
