Senior Manufacturing Systems Engineer: BAS/QBAS

Role Summary

Senior Manufacturing Systems Engineer: BAS/QBAS. Provide automation technical leadership to a group of automation engineers responsible for building and maintaining automation systems supporting GMP Drug Substance Plant Operations. Work with the Facilities & Engineering Automation team and capital project teams to deliver robust automation systems for the new plant, including complex initiatives across multiple platforms, integration, lifecycle management, and Operational Excellence.

Responsibilities

• Maintain the Building Automation System (BAS) on Siemens Desigo CC.
• Work with process SMEs to understand key process requirements and translate them into digital automated solutions.
• Collaborate with business partners to improve workflow and productivity through automation of utility and building equipment systems; synthesize requirements from clients to develop optimal automation solutions.
• Provide clear documentation for delivered solutions and processes; support computerized systems validation in a GxP environment; maintain Data Integrity Assessments.
• Maintain detailed specifications and engineering policies affecting multiple units.
• Support commissioning and qualification efforts including IV/ACO.
• Lead and support projects to improve equipment/utilities/facilities and integrate new manufacturing technologies.
• Lead/support root cause analyses, incident investigations, and troubleshooting of utilities and BAS controls.
• Lead/support NPI or new technology introductions through assessments, configuration changes, and process qualification support.
• Handle day-to-day Operational Support including 24x7 onsite/on-call support, troubleshooting, maintenance, and spare parts management.
• Pursue innovative approaches to improve efficiency and cost effectiveness.

Qualifications

• Basic Qualifications:
  • High School Diploma / GED and 10 years of Engineering experience OR
  • Associate’s Degree and 8 years of Engineering experience OR
  • Bachelor’s Degree and 4 years of Engineering experience OR
  • Master’s Degree and 2 years of Engineering experience OR
  • Doctorate Degree
• Preferred Qualifications:
  • Degree in Electrical Engineering or Computer Science, Chemical Engineering or Biotech Engineering.
  • Direct knowledge of BAS design, building control engineering, GMP biopharmaceutical production facility automation, and integration of OEM software.
  • Experience in programming, design, installation, and lifecycle management of building automation controls, PLCs, and instrumentation.
  • Experience with Siemens BAS, Rockwell automation, OPC, Foundation Fieldbus, Profibus, and DeviceNet technologies.
  • Ability to interpret and apply GAMPs and GMPs; familiarity with 21 CFR Part 11, ASTM 2500, S88, S95.
  • Experience in Capital Project Lifecycle Management and project implementation.
  • Track record of continuous improvement in safety, reliability, and productivity.
  • Self-directed, strong teammate, mentoring ability, and collaborative decision-making.
  • Strong leadership, technical writing, and communication skills.

Education

• As specified in Basic Qualifications above (Degrees in Engineering or related fields).