Instrumentation and Controls System Owner

I&C (Instrumentation & Controls) System Owner Indianapolis About Us Atlantach Technical Services is an engineering and technical solutions company specializing in Construction Management, Project Management, Commissioning and Operations & Maintenance. Industries we work in Semi-Conductor | Pharma | Med Device | Data center | Automotive Worldwide Operations Ireland | Europe| USA Join Our Team At Atlantach Technical Services, Ambition drives us to continuously improve and grow. Teamwork strengthens our collaboration and respect. Success is achieved together. Join us in shaping your career, where ambition is realised, teamwork is at our core and success is celebrated. We are seeking to hire a I&C (Instrumentation & Controls) System Owner to join our company in Indianapolis. You will be responsible for installation of I&C systems in the pharmaceutical industry

Duties and Responsibilities:

• Own I&C systems across design, construction, commissioning, and qualification phases
• Review and approve control system documentation (URS, FRS, DDS, control narratives)
• Ensure compliance with FDA regulations, cGMP, and GAMP5 requirements
• Coordinate with EPCM, automation vendors, and CQV teams
• Oversee

PLC/SCADA/DCS

configuration, integration, and testing

• Support and witness FAT, SAT, and site acceptance activities
• Lead loop checks, functional testing, and commissioning execution
• Manage deviations, CAPAs, and change control within quality systems
• Troubleshoot control system issues and drive resolution to closure
• Review and approve IQ/OQ protocols and summary reports
• Ensure complete turnover packages (as-builts, software backups, asset data)
• Support process validation and site startup readiness

Authority:

• You have authority to stop the job if you feel there is an unsafe work practice which could result in a risk of injury, have an environmental impact or risk to equipment and other personnel.
• Carry out your duties to meet Quality, Safety and Environmental requirements at all times. Requirements
• Bachelor's degree in Engineering (Controls, Electrical, Instrumentation or related)
• 5-10+ years in pharma/biotech with automation or controls focus
• Strong knowledge of

FDA 21 CFR

Part 11, cGMP, and GAMP5

• Hands-on experience with

PLC/DCS/SCADA

(e.g., DeltaV, Rockwell, Siemens PCS7)

• Experience with CQV lifecycle (commissioning, qualification, validation)
• Ability to read and interpret P&IDs, control strategies, and cause & effect matrices
• Knowledge of network architecture and industrial cybersecurity (ISA/IEC 62443 a plus)
• Strong experience with change control, deviations, and audit readiness
• Vendor and stakeholder management experience in large capital projects
• Strong communication and documentation skills Benefits
• Competitive salary
• Health, Dental, and Vision
• 401(k) with employer match

Benefits:

401(k) Dental insurance Health insurance Paid time off Referral program Vision insurance

Work Location:

In person