Title: Operational Technology Engineer
Location: Central Florida, USA
Work Arrangement: Onsite
Work Schedule: Monday – Friday, with weekend support as business needs require
Employment Type: Temporary Contract – 5 Months
Candidate Eligibility: Direct candidates only. Staffing vendor and third-party candidate submissions will not be accepted.
Position Summary
Our client is seeking an experienced Operational Technology (OT) Engineer to support Computer System Validation (CSV), Data Integrity, regulatory compliance, and automation initiatives within a cGMP-regulated pharmaceutical manufacturing environment. The primary focus of this position will be Computer System Validation (CSV) and Data Integrity rather than automation alone. The selected candidate will be responsible for validating systems, ensuring data integrity and regulatory compliance, identifying gaps in existing systems and documentation, and implementing improvements to maintain compliance and operational effectiveness.
While automation is an important component of the role, it represents a smaller portion of the overall responsibilities. Automation-related activities will primarily focus on Building Management Systems (BMS), particularly the Honeywell Niagara and Inductive Automation Ignition platforms.
Key Responsibilities
- Execute and support Computer System Validation (CSV) activities to ensure systems meet applicable regulatory and quality requirements.
- Assess and maintain Data Integrity across computerized systems and operational technology environments.
- Ensure systems and associated documentation comply with applicable regulatory standards and industry requirements.
- Identify gaps, deficiencies, and compliance risks within existing systems, processes, and documentation.
- Develop and implement corrective actions and improvements to address identified gaps.
- Review, prepare, and maintain validation documentation in accordance with established procedures and regulatory expectations.
- Provide technical support for PLCs, HMIs, SCADA, BMS/EMS, industrial networks, servers, and OT systems.
- Troubleshoot manufacturing and facility automation issues while minimizing operational downtime.
- Support Change Controls, Deviations, CAPAs, investigations, and CSV activities.
- Maintain system documentation, backups, access management, and disaster recovery processes.
- Support equipment installations, commissioning, qualification, validation, and automation upgrades.
- Provide technical support for Building Management Systems (BMS), particularly Honeywell Niagara and Inductive Automation Ignition platforms.
- Coordinate with Engineering, Maintenance, Quality, Validation, IT, vendors, and Original Equipment Manufacturers (OEMs).
- Collaborate with cross-functional teams to maintain system reliability, compliance, and operational effectiveness.
Minimum Qualifications
- Bachelor's degree in Engineering or a related technical field (preferred).
- Experience supporting Operational Technology (OT) within a cGMP-regulated pharmaceutical environment.
- Hands-on experience with PLCs, HMIs, SCADA, BMS/EMS, industrial networks, servers, and databases.
- Knowledge of Data Integrity, 21 CFR Part 11, Change Control, CAPAs, Deviations, and Computerized System Validation (CSV).
- Strong troubleshooting, technical documentation, and communication skills.
Preferred Experience
- Experience with automation platforms such as Rockwell/Allen-Bradley, Siemens, Schneider, or Honeywell.
- Pharmaceutical manufacturing experience.
- Experience supporting equipment commissioning and qualification.
- Knowledge of OT cybersecurity principles and practices.
Work Environment and Schedule
- Onsite position in Central Florida, USA.
- Monday through Friday schedule.
- Weekend support may be required based on business needs.
- Temporary contract duration of five (5) months.
Submission Requirements
- Open to direct candidates only.
- Staffing vendor, third-party, and agency submissions will not be accepted.