Role Overview
We are seeking an experienced IT/OT Lead to drive digital transformation and system integration across pharmaceutical manufacturing operations. The role requires strong leadership in bridging Information Technology (IT) and Operational Technology (OT) ensuring seamless connectivity between enterprise systems automation platforms and shop-floor operations.
The IT/OT Lead will oversee MES DeltaV/DCS PLC SCADA and ERP integrations ensuring compliance with GxP CSV and cybersecurity standards while enabling Pharma 4.0 initiatives
Key Responsibilities
- Lead IT/OT strategy and execution across global pharma manufacturing sites.
- Manage integration of MES (PAS-X Opcenter Syncade) with automation systems (DeltaV PCS7 PLC SCADA).
- Oversee system architecture network design and cybersecurity aligned with IEC 62443 and NIST standards.
- Drive digital plant initiatives including data historians IoT/IIoT cloud adoption and analytics platforms.
- Ensure compliance with GxP FDA 21 CFR Part 11 and CSV requirements.
- Collaborate with engineering QA and manufacturing teams to optimize IT/OT workflows.
- Manage vendor relationships system upgrades and lifecycle management of automation/IT systems.
- Provide leadership in disaster recovery business continuity and system resilience planning.
Qualifications
- Bachelors/Masters in Engineering Computer Science or related discipline.
- 15 years of IT/OT experience in pharma/life sciences manufacturing.
- Proven expertise in MES DCS/DeltaV PLC SCADA ERP integration.
- Strong knowledge of GxP CSV FDA EMA regulatory frameworks.
- Experience in cybersecurity for OT systems (IEC 62443 NIST).
- Familiarity with cloud platforms (Azure/AWS) IoT/IIoT and data analytics.
- Excellent leadership stakeholder management and communication skills.
Role Overview We are seeking an experienced IT/OT Lead to drive digital transformation and system integration across pharmaceutical manufacturing operations. The role requires strong leadership in bridging Information Technology (IT) and Operational Technology (OT) ensuring seamless connectivity bet...
Role Overview
We are seeking an experienced IT/OT Lead to drive digital transformation and system integration across pharmaceutical manufacturing operations. The role requires strong leadership in bridging Information Technology (IT) and Operational Technology (OT) ensuring seamless connectivity between enterprise systems automation platforms and shop-floor operations.
The IT/OT Lead will oversee MES DeltaV/DCS PLC SCADA and ERP integrations ensuring compliance with GxP CSV and cybersecurity standards while enabling Pharma 4.0 initiatives
Key Responsibilities
- Lead IT/OT strategy and execution across global pharma manufacturing sites.
- Manage integration of MES (PAS-X Opcenter Syncade) with automation systems (DeltaV PCS7 PLC SCADA).
- Oversee system architecture network design and cybersecurity aligned with IEC 62443 and NIST standards.
- Drive digital plant initiatives including data historians IoT/IIoT cloud adoption and analytics platforms.
- Ensure compliance with GxP FDA 21 CFR Part 11 and CSV requirements.
- Collaborate with engineering QA and manufacturing teams to optimize IT/OT workflows.
- Manage vendor relationships system upgrades and lifecycle management of automation/IT systems.
- Provide leadership in disaster recovery business continuity and system resilience planning.
Qualifications
- Bachelors/Masters in Engineering Computer Science or related discipline.
- 15 years of IT/OT experience in pharma/life sciences manufacturing.
- Proven expertise in MES DCS/DeltaV PLC SCADA ERP integration.
- Strong knowledge of GxP CSV FDA EMA regulatory frameworks.
- Experience in cybersecurity for OT systems (IEC 62443 NIST).
- Familiarity with cloud platforms (Azure/AWS) IoT/IIoT and data analytics.
- Excellent leadership stakeholder management and communication skills.
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