Senior Operations Manager

Role:-Senior Operational Technology (OT) Executive

Industry: Pharmaceutical / Life Sciences(MUST)

Location:-New Jersey,USA

Experience: 5-8+ Years

Employment Type: W2 Contract

Job Summary:-

We are seeking a Senior Operational Technology (OT) Executive with strong experience in pharmaceutical manufacturing, OT systems, automation, CSV, GxP compliance, and IT/OT infrastructure . The candidate will support critical manufacturing, laboratory, and utility systems while ensuring system reliability, security, and regulatory compliance.

Key Responsibilities:-

• Manage and support SCADA, DCS, PLC, HMI, Historian, MES, BMS, and EMS systems.
• Support GxP computerized systems used in pharmaceutical manufacturing and laboratories.
• Execute and maintain Computer System Validation (CSV) activities.
• Prepare/review URS, Risk Assessments, IQ/OQ/PQ, RTM, Validation Reports, and Periodic Reviews .
• Ensure compliance with GAMP 5, 21 CFR Part 11, EU Annex 11, and ALCOA+ .
• Manage user access, Active Directory, roles, permissions, audit trails, and security controls .
• Support OT networks, VLANs, switches, firewalls, Windows Servers, VMware/Hyper-V, and databases .
• Troubleshoot OT applications, automation systems, hardware, and software issues.
• Support FAT, SAT, commissioning, qualification, system upgrades, and implementation projects .
• Manage incident, change control, preventive maintenance, backup, and disaster recovery activities.
• Support OT cybersecurity and data integrity initiatives.
• Coordinate with QA, QC, Engineering, Automation, Production, IT, and external vendors .
• Support FDA/MHRA/EMA audits and regulatory inspections by providing validation and technical documentation.
• Maintain SOPs, work instructions, configuration documents, network diagrams, asset inventories, and validation records .
• Mentor junior OT team members and provide technical support/training.

Required Skills:-

• 8+ years of OT / Automation / CSV experience in Pharma or Life Sciences
• SCADA / DCS / PLC / HMI / Historian
• MES / BMS / EMS
• CSV and GxP compliance
• GAMP 5 / 21 CFR Part 11 / EU Annex 11 / ALCOA+
• Active Directory / Windows Server
• VMware / Hyper-V
• SQL Server / Oracle
• OT Networking / VLAN / Firewall / Switches
• OT Cybersecurity
• Backup & Disaster Recovery
• Strong documentation and troubleshooting skills
• Vendor and cross-functional team management