Automation Engineer II

Matica Biotechnology•College Station, TX

About The Position

The Automation Engineer II implements, configures, integrates, troubleshoots, and supports the lifecycle of process-control, automation, laboratory, and OT systems across Manufacturing, Quality Control, Analytical, and Process Development. The role provides independent hands-on technical support, executes assigned system improvements and automation projects, and helps ensure the reliability, efficiency, and compliance of critical systems in a regulated biopharmaceutical manufacturing environment. The engineer works with Manufacturing, Quality, Process Development, IT, and external vendors to resolve issues and support commissioning, qualification, and validation. As competency develops, the engineer may coordinate defined project activities under supervisor or senior-engineer guidance. The position includes support for automated process equipment and laboratory systems, investigation and root-cause analysis of process-control issues, configuration and routine monitoring of computerized systems, and support for system enhancements and new technologies. It also includes OT/IT integration, Windows system administration, user access management, industrial networking, data backups, and coordination with IT. The engineer helps maintain compliance with GxP, 21 CFR Part 11, ALCOA+ data-integrity requirements, company procedures, and applicable change-control and validation practices. The role also uses BMS, BAS, and EMS systems to control building utilities and contributes to continuous improvement, client-program and tech-transfer support, system standardization, and user training.

Requirements

Bachelor’s degree in engineering (Automation, Electrical, Mechanical, Chemical, Computer Engineering, or related discipline), Computer Science, or a related technical field is preferred; an associate degree in a relevant technical discipline combined with relevant professional experience and demonstrated technical competency will also be considered.
3–6 years of relevant experience in automation, process control, instrumentation, or OT systems in biopharmaceutical, pharmaceutical, medical-device, or other regulated manufacturing environments; equivalent demonstrated capability may be considered.
Hands-on experience configuring, supporting, and troubleshooting PLC, DCS, SCADA, or HMI platforms, such as DeltaV, Rockwell/Allen-Bradley, Siemens, or equivalent.
Working knowledge of GxP, ALCOA+ data integrity, and relevant ISA, ISPE, and GAMP 5 practices.
Experience executing assigned system upgrades, integrations, commissioning, qualification and validation (IQ/OQ/PQ), documentation, and change-control activities.
Practical OT/IT experience with Windows, user administration, Active Directory, backups, patching, basic networking, and coordination with IT for secure connectivity.
Ability to troubleshoot routine to moderately complex problems independently, document root causes and corrective actions, and escalate issues appropriately.
Good understanding of and ability to manage and use BMS, BAS, and EMS systems.
Experience collaborating with Manufacturing, Quality, IT, Process Development, and vendors and managing competing technical priorities.
Ability to follow SOPs, deviation processes, and change-control procedures.
Knowledge of FDA 21 CFR Parts 210/211 and Part 11, electronic records, and ALCOA+ data-integrity principles.
Knowledge of ISA frameworks, ISO standards, ISPE guidance, and GAMP 5.
Knowledge of computerized-system validation and risk-based qualification and testing documentation.
Knowledge of quality processes, including change control, deviations, CAPAs, and investigations.
Knowledge of automation architecture, OT connectivity, and cybersecurity fundamentals.
Independent hands-on problem-solving, sound technical judgment, and appropriate escalation.
Ability to manage assigned workstreams, priorities, and deliverables while collaborating effectively across functions.
Strong technical documentation and communication skills, including the ability to guide end users and less experienced engineers.
Initiative and commitment to development, with the ability to progressively assume project coordination and technical leadership of defined activities under supervisor or senior-engineer guidance.

Nice To Haves

Vendor automation certifications such as Emerson DeltaV, Rockwell, or Siemens.
Networking or cybersecurity credentials such as CompTIA, CCNA, or ISA/IEC 62443.
Microsoft infrastructure credentials or GMP/CSV training.
Experience with manufacturing or laboratory equipment such as bioreactors, TFF, chromatography, fill/finish, or analytical instruments.
Familiarity with VMware or Hyper-V.

Responsibilities

Provide day-to-day independent technical support for configuration, integration, maintenance, and troubleshooting of automated process equipment, including PLC, DCS, SCADA, HMI, analytical equipment and instruments, and laboratory automation systems.
Collaborate with end users and vendors to resolve technical issues.
Investigate automation and process-control issues, conduct root-cause analysis, recommend corrective actions, and work with cross-functional teams and vendors to minimize disruptions.
Execute assigned automation projects, system enhancements, and technical workstreams, including configuration, testing, documentation, vendor coordination, and commissioning, qualification, and validation support (IQ/OQ/PQ).
As technical competency develops, coordinate activities and lead defined portions of projects under supervisor or senior-engineer guidance.
Participate in projects to optimize automation processes, improve system performance, and implement technologies that enhance efficiency and data integrity.
Deliver training, coaching, or guidance to peers and end users on proper use of automated systems, working with Manufacturing, Quality, and Process Development.
Perform configuration, user-access management, data backup and restore, and routine monitoring of computerized systems.
Support commissioning, qualification, validation, and change-control activities for automation and analytical systems in alignment with GxP requirements and company procedures.
Maintain systems in compliance with GxP, 21 CFR Part 11, and ALCOA+ data-integrity requirements, including access management, audit trails, backups, change control, validated configurations, and accurate documentation of activities, deviations, and changes.
Support OT/IT integration, including Windows system administration, Active Directory, industrial networking, secure connectivity, and coordination with IT.
Contribute to continuous improvement, client-program and tech-transfer support, system standardization, and training or technical guidance for end users and less experienced engineers.
Use BMS, BAS, and EMS systems for controlling building utilities.
Perform other duties as assigned.