Technical Leadership & Lifecycle Management: Provide hands-on leadership for the design, configuration, integration, qualification, and lifecycle management of control systems across plant and lab operations. System Troubleshooting & Root Cause Analysis: Lead advanced troubleshooting for process control systems???including PLC, DCS, SCADA, and equipment-level automation???to support uninterrupted GMP operations. Project Execution & Qualification: Manage automation project implementations, requirement definitions, and vendor coordination while supporting commissioning and qualification (IQ/OQ/PQ) activities. Compliance & Data Integrity: Ensure system configurations, electronic records, and audit trails comply with GxP, 21 CFR Part 11, and ALCOA+ data integrity standards. Client Programs & Tech Transfer: Support tech transfer activities, client program customizations, client meetings, and regulatory inspections/audits. Continuous Improvement: Identify and execute continuous improvement initiatives to optimize system reliability, scalability, and operational efficiency within a CDMO environment. Mentorship: Offer technical guidance, coaching, and mentorship to junior automation engineers to build capability and promote engineering standardization.
4-7 years
Education & Experience: Bachelor's degree in Engineering (Chemical, Electrical, Mechanical, Computer, or related) with 6-12+ years of automation/process control/OT experience in biopharmaceutical or regulated manufacturing. Automation Platform Expertise: Demonstrated design, implementation, and lifecycle management skills in DCS, PLC, SCADA, and HMI platforms (e.g., DeltaV, Rockwell/Allen-Bradley, Siemens). Regulatory & Validation Compliance: In-depth working knowledge of FDA regulations (21 CFR Parts 210/211 and Part 11), ALCOA+ data integrity, Computerized System Validation (CSV), GAMP 5, and ISA-88/ISA-95 frameworks. Commissioning & Qualification: Hands-on experience executing IQ/OQ/PQ validation protocols, deviation management, CAPA, and change control within GMP environments. Bioprocessing Equipment: Experience supporting bioprocess systems such as single-use bioreactors, filtration (TFF), and chromatography systems. OT/IT & Industrial Networking: Proficiency in OT asset management in Windows environments, Active Directory (AD) integration, industrial network architecture (switches, firewalls, VLANs), and cybersecurity principles (e.g., NIST, ISA/IEC 62443). Problem-Solving & Soft Skills: Excellent root cause analysis abilities, communication, documentation, and the capacity to balance hands-on work with strategic initiatives in a lean organization.
Advanced Bioprocessing: Direct experience with biopharmaceutical fill/finish systems. Industry Certifications:Automation certifications (e.g., Emerson DeltaV, Siemens, or Rockwell Automation). Industrial cybersecurity or networking certifications (e.g., ISA/IEC 62443, CompTIA Security+, Cisco CCNA). IT certifications (e.g., Microsoft Certified Windows Server/Active Directory, Azure Fundamentals). Project Management certification (e.g., PMP). Infrastructure Knowledge: Practical experience managing virtualization platforms such as VMware and Hyper-V.
Bachelors
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