Manufacturing Automation CSA Program Lead (GMP) Your Challenge: As we scale our advanced manufacturing capabilities, we need a visionary leader to architect and execute our holistic Automation Quality, Compliance, and Computer Software Assurance (CSA) strategy. The GMP Automation CSA Program Lead will bridge strategic quality oversight, automation governance, and operational excellence. Deep technical expertise in GMP manufacturing automation is mandatory, as is a proven track record of strategic thinking in CSV/CSA execution. You will move compliance from a defensive testing exercise to a streamlined, risk-based enabler of modern manufacturing—orchestrating global automation quality standards, driving data integrity, and establishing modern CSV/CSA paradigms across our state-of-the-art GMP facilities. ...in Our Journey: You will serve as the organizational authority on automation compliance and program oversight, setting the tone for how we govern manufacturing execution systems, control systems, and data infrastructure. By applying CSIA Best Practices and FDA CSA guidance to critical OT assets, you will build scalable validation and assurance frameworks that safeguard product quality and patient safety while accelerating technology deployment and operational readiness. Position SummaryThe GMP Automation CSA Program Lead provides high-level strategic direction, program governance, and operational oversight for all automated and computerized systems operating in our regulated GMP manufacturing network. This pivotal role defines system lifecycle policies, drives risk-proportionate software assurance frameworks, and maintains full alignment with international regulatory expectations and industrial automation standards. Functioning at a directorial level of strategic oversight, you will lead the cross-functional integration of Automation, Quality Assurance, IT/OT Infrastructure, Manufacturing Operations, and Engineering. The position commands solid technical mastery over industrial automation platforms (e.g., Emerson DeltaV, SCADA, PLCs, OSIsoft/AVEVA PI System) paired with advanced strategic vision in risk-based assurance frameworks (FDA CSA, GAMP 5 2nd Edition) and industrial governance standards (CSIA Best Practices) to maximize system reliability, data integrity, and inspection readiness.

Key Responsibilities
Strategic CSA Program Governance & Lifecycle Architecture
• Define Enterprise Automation CSA Strategy: Formulate and enforce company-wide program roadmaps and computerized software assurance (CSA) frameworks tailored for complex, multi-tiered GMP automation architectures.
• Strategic CSV/CSA Vision: Drive the paradigm shift from traditional document-heavy CSV to modern, risk-proportionate FDA CSA principles—aligning compliance effort directly with critical process parameters (CPPs), critical quality attributes (CQAs), and direct patient/product safety impacts.
• CSIA Compliance Framework: Direct the integration of CSIA (Control System Integrators Association) Best Practices across system lifecycle management, vendor oversight, project execution, and OT system sustainability.
• Capital Project Governance: Serve as the lead compliance strategist for capital expenditure projects, system migrations, expansions, DeltaV upgrades, and enterprise historian deployments. System Lifecycle & Technical Documentation Governance
• GMP Automation Architectural Oversight:



Establish standard operating procedures for system architecture specifications, user requirements (URSs), functional specifications (FSs), and data flow maps across all automation levels (Level 0–Level 3).
• Defensible Program Portfolios: Drive enterprise traceability models and oversee the lifecycle documentation suite (Validation Plans, Risk Assessments, IQ/OQ/PQ, Traceability Matrices, and Summary Reports) to maintain defensible, audit-ready compliance evidence.
• Vendor & Integrator Strategy: Define technical and compliance benchmarks for external system integrators and automation suppliers. Conduct strategic reviews of vendor Quality Management Systems (QMS) to maximize the leveraging of supplier testing and FAT/SAT documentation under CSA guidelines. Next-Generation Assurance & Testing Execution Strategy
• Advanced CSA Testing Methodologies: Lead the design and deployment of objective-driven testing strategies—leveraging continuous integration, automated testing tools, and unscripted testing techniques where appropriate under CSA guidance.
• Control Loop & Advanced Automation Verification: Apply deep GMP automation knowledge to provide subject matter expertise on the strategic assurance and quality oversight of complex control logic, batch management (ISA-88), phase logic, permissive matrices, alarm management (ISA-18.2), and interlock architectures.
• Operational Readiness & Handover: Establish governance policies for seamless system transitions from project delivery into site operations, continuous monitoring, and ongoing program ownership. Data Integrity, Cybersecurity & Risk Management
• ALCOA+ Framework Governance: Establish site-wide data integrity strategies for automated systems, ensuring robust design controls for electronic records, electronic signatures (21 CFR Part 11 / EU Annex 11), audit trails, and system access models.
• OT Cybersecurity & Resilience: Align automation assurance strategies with industrial cybersecurity frameworks (ISA/IEC 62443, CSIA guidelines) to defend against OT threats, secure time synchronization, enforce backup/disaster recovery protocols, and ensure business continuity.
• Lifecycle Data Flow Auditing: Direct comprehensive data integrity and functional risk assessments across interconnected control systems, enterprise historians, and manufacturing execution systems (MES). Quality Systems & Inspection Readiness Strategy
• Change Control & Impact Governance: Serve as the final authority on change control impact assessments for automation platforms, ensuring that hardware, software, configuration, and patch changes undergo risk-proportionate verification without stifling innovation.
• Deviation & Root Cause Oversight: Lead high-level investigations, CAPAs, and continuous improvement initiatives stemming from automation events, software exceptions, or data anomalies.
• Regulatory Inspection Leadership: Represent the company as the primary Subject Matter Expert (SME) during regulatory agency inspections (FDA, EMA, MHRA) and client audits, articulate the site’s risk-based CSA strategy,



and defend automated control paradigms. Executive Collaboration & Program Delivery
• Cross-Functional Leadership: Direct cross-functional alignment between Automation Engineering, Quality Assurance, IT/OT, Manufacturing, and Executive Leadership to ensure operational readiness and compliance coherence.
• Resource & Integrator Oversight: Manage external validation partners, managed services, and system integrators
- ensuring alignment with program timelines, fiscal budgets, and quality standards.
• Operational Modernization: Continually benchmark internal automation practices against evolving regulatory guidance, ISPE GAMP trends, CSIA guidelines, and Industry 4.0 automation practices. Required Qualifications (Must-Haves)
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Education:
Bachelor’s or Master’s degree in Engineering (Electrical, Chemical, Automation, Biomedical), Computer Science, or a related technical discipline.
• Core Mastery (Must-Have): Solid, hands-on technical expertise in GMP manufacturing automation paired with proven strategic vision in Computer System Validation (CSV) and Computer Software Assurance (CSA) within a regulated environment.
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Experience:
8+ years of progressive experience in computer system validation/assurance, automation quality engineering, or automation engineering within a regulated pharmaceutical, biotechnology, or medical device manufacturing setting, with demonstrated experience leading program-level compliance strategies.
• Regulatory & Framework Expertise:
• Deep, practical working knowledge of FDA Computer Software Assurance (CSA) guidance, ISPE GAMP 5 (2nd Edition), 21 CFR Part 11, and EU GMP Annex 11.
• Strong working knowledge and experience implementing CSIA (Control System Integrators Association) Best Practices for project management, system development, and program governance.
• Technical Automation Mastery: Hands-on and architectural depth with industrial automation technologies, including Emerson DeltaV, SCADA systems, PLCs (Allen-Bradley/Siemens), AVEVA PI / OSIsoft PI Historian, batch execution systems (ISA-88), and industrial networks/interfaces (OPC, Modbus, Ethernet/IP).
• Data Integrity & Risk: Proven track record of applying risk-based quality management principles (ICH Q9) and ALCOA+ data integrity standards to automation platforms and infrastructure.
• Inspection Defense: Demonstrated success in leading inspection readiness programs and defending computerized automation systems directly to regulatory authorities (FDA, EMA, etc.).
• Communication & Strategic Influence: Exceptional communication, executive presentation, and consensus-building skills with the ability to articulate complex automation concepts to both technical SMEs and non-technical executive leadership. Preferred Qualifications
• Active involvement in professional industry bodies (e.g., ISPE, CSIA, MESA, IEEE, ASQ).
• Certified CSIA Lead or experience driving CSIA certification for internal engineering organizations or integrator partners.
• Experience integrating Level 2 automation control systems with Level 3/4 enterprise systems (e.g., MES, Syncade, Werum PAS-X, ERP, LIMS).
• Direct leadership experience managing capital automation program budgets, external engineering service providers, and system integrators.
• Deep knowledge of OT cybersecurity protocols and convergence architectures (ISA/IEC 62443).

📌 Manufacturing Automation CSA Program Lead (Hyderabad)
🏢 Zoho
📍 Hyderabad