Automation Engineer III

Matica Biotechnology is at the forefront of biopharmaceutical research and development. The Matica Bio team brings an average of 15 years of cell and viral vector manufacturing experience to the development and manufacture of advanced therapy products. At our purpose-built GMP facility in College Station, Texas, we provide rapid development and scale-up of cell and gene therapies, vaccines, and Oncolytics meeting worldwide regulatory compliance.

The true value of a CDMO is determined by the quality of its people. Matica Bio consists of a dedicated team of experts. We’re a cell and gene therapy CDMO powered by people, and our people provide real benefits to the quality, safety and speed of the cell and gene therapy development pathway. Our inventive thinking and foresight help us strategize the best path to take therapies from the lab to the market. Come join our dedicated team and Make it Happen With Matica Bio!

The Automation Engineer III is responsible for leading the design, integration, and lifecycle management of process control, automation, and laboratory/OT systems across the organization. This role serves as the senior technical authority, providing advanced troubleshooting, systems strategy, and project leadership to ensure the reliability, efficiency, and compliance of critical automated systems within Manufacturing, Quality Control, Analytical, and Process Development areas.

The Automation Engineer III partners with cross-functional teams and external vendors to drive new technology introductions, system upgrades, and continuous improvement initiatives aligned with regulatory requirements and industry best practices. In addition, this position provides mentorship and technical guidance to junior engineers, including the Automation Engineer I and II, fostering knowledge transfer, standardization, and long‑term capability development within the Automation Technology function. Success in this role requires deep expertise in process control and automation platforms, strong leadership in regulated environments, and the ability to balance hands‑on technical work with strategic oversight.

How you will make an impact:

• Provide hands‑on technical leadership for the design, configuration, integration, qualification, and lifecycle management of automation and control systems across manufacturing, laboratory, and facility operations.
• Lead advanced troubleshooting and root cause analysis of process control systems, including PLC, DCS, SCADA, and equipment‑level automation, ensuring rapid resolution of issues impacting GMP operations.
• Manage and execute automation projects and system implementations, including requirements definition, vendor coordination, and system implementation, and provide support for commissioning and qualification activities (IQ/OQ/PQ) in alignment with regulatory expectations.
• Ensure systems meet GxP, 21 CFR Part 11, and data integrity (ALCOA+) requirements, including audit trails, electronic records, and validated system configurations.
• Support client programs and tech transfer activities, including customization of automation strategies, participation in client meetings, and support during audits and regulatory inspections.
• Drive continuous improvement initiatives, identifying opportunities to enhance system reliability, scalability, and operational efficiency in a fast‑paced CDMO setting.
• Mentor and provide technical guidance to junior automation engineers, promoting standardization, knowledge transfer, and strong engineering practices.

As a future Matican you bring:

Education

• Bachelor’s degree in Engineering (e.g., Chemical, Electrical, Mechanical, Computer Engineering, or related discipline) required.

Experience

• 6–12+ years of experience in automation, process control and OT systems within biopharmaceutical or other regulated manufacturing environments
• Demonstrated expertise in the design, implementation and lifecycle management of automation platforms, including Distributed Control Systems (DCS), Programmable Logic Controllers (PLC), SCADA and HMI systems (e.g., DeltaV, Rockwell/Allen‑Bradley, Siemens, or equivalent).
• Strong working knowledge of regulatory requirements and industry standards, including GxP, data integrity (ALCOA+ principles), and frameworks such as ISA-88, ISA-95, ISPE guidelines, and GAMP 5.
• Proven experience leading complex automation projects, including system integration, commissioning, qualification/validation (IQ/OQ/PQ) and change control in regulated environments.
• Hands‑on experience with OT/IT integration, including:
  • Managing automation assets within Windows‑based environments
  • Supporting Active Directory (AD) domain integration (e.g., user/group management, Group Policy considerations, domain joining of systems)
  • Coordinating with IT to ensure proper network architecture segmentation and secure connectivity for automation systems
  • Configuring and troubleshooting networked devices (e.g., switches, firewalls, VLANs) within an industrial control system environment
• Hands‑on experience supporting bioprocessing equipment, including:
  • Single‑use bioreactors
  • Filtration systems (e.g., TFF)
  • Chromatography systems
  • Fill/finish systems (preferred)
• Strong understanding of industrial network architecture and cybersecurity principles, including secure system design, access control, patching strategies, and alignment with frameworks such as NIST or ISA/IEC 62443.
• Proven experience executing commissioning, qualification, and validation (IQ/OQ/PQ) of automated systems in GMP environments
• Extensive experience in troubleshooting and root cause analysis of control systems, including integration points between manufacturing equipment laboratory systems and enterprise systems.
• Experience supporting automation systems across multiple functional areas, such as Manufacturing, Process Development, Quality Control laboratories, and Facilities/Utilities (e.g., clean utilities, HVAC, BMS/EMS, Environmental Monitoring and alarm management).
• Demonstrated ability to lead cross‑functional initiatives and influence stakeholders at multiple levels, including collaboration with Quality, IT, Manufacturing, and external vendors.
• Demonstrated ability to support client interactions, tech transfer, and regulatory inspections
• Prior experience mentoring or providing technical leadership to junior engineers, including oversight of deliverables, technical coaching and knowledge transfer.
• Strong project management skills, with the ability to manage multiple priorities, balance hands‑on technical work strategic initiatives, and deliver results within timelines and compliance requirements.
• Excellent communication and documentation skills, including the ability to support audits, inspections and clearly translate between IT and OT domains.

Leadership & Soft Skills

• Strong problem‑solving and hands‑on troubleshooting capability
• Ability to operate effectively in a lean organization, balancing strategic thinking with direct execution
• Proven ability to lead cross‑functional initiatives and influence stakeholders across Manufacturing, Quality, IT, and external vendors
• Strong communication and documentation skills, including support for audits and technical reports

Licenses or Certifications

• Industry‑recognized automation certifications (e.g., vendor certifications from Siemens, Rockwell Automation, or Emerson Electric such as DeltaV certification) are a plus.
• Certifications in industrial cybersecurity or networking (e.g., ISA/IEC 62443 Cybersecurity Certificate, CompTIA Security+, Cisco CCNA) are a plus.
• Project Management certification (e.g., PMP) is desirable for leading complex initiatives are a plus.
• IT‑related certifications (e.g., Microsoft Certified: Windows Server / Active Directory, Azure Fundamentals) are a plus given OT/IT integration responsibilities.

Knowledge

• FDA regulations and global compliance frameworks, including 21 CFR Parts 210 & 211 and 21 CFR Part 11, with strong emphasis on data integrity principles (ALCOA+).
• Industry standards and best practices, including ISA frameworks, ISO standards and Good Automated Manufacturing Practice (GAMP 5).
• Computerized System Validation (CSV) lifecycle, including risk‑based validation strategies and documentation in regulated environments.
• Quality systems and processes, including electronic Quality Management Systems (eQMS), Change Control, CAPA, Deviations and Investigations.
• Infrastructure and industrial networking concepts, including system architecture segmentation and secure connectivity within OT environments.
• Virtualization platforms and infrastructure management, including VMware and Hyper‑V.

Commitment to Excellence, Problem Solving/Decision Making/Analytical Thinking, Communication Skills, Teamwork/Cooperation/Supportiveness, Flexibility/Adaptability, Initiative/Taking Ownership, Focus on Safety, Ethical/Trustworthiness, Work Ethic/Reliability, Thoroughness, Customer Service

We Value:

Matica’s Values are at the forefront of everything we do, our culture, and the decisions we make.

• Start with Safety & Quality
• Choose the Path of Openness, Honesty, and Integrity
• Nurture Our Differences to Enable Our Collective Success
• Learn Continuously to Ensure Our Value and Relevance
• Commit to Delivering Life Altering Therapies