Lead the adoption and operation of Manufacturing Execution Systems (MES) and Global SCADA across APAC, managing a distributed team and ensuring delivery of technology initiatives.
Responsibilities
Lead, coach, develop and manage a distributed team supporting APAC MES and Global SCADA activities.
Establish clear expectations, objectives, plan & resource allocation, governance, accountability, and performance measures for team members.
Ensure clear and effective communication.
Foster a culture of ownership, urgency, collaboration, and continuous improvement across the team.
Develop strategy for extending knowledge of the team as needed.
Requirements
Bachelor’s Degree in Information Technology, Engineering, Computer Science, Automation or related discipline
Drive IT platform and application governance throughout the system development lifecycle, including design, development, release, change management, and retirement, ensuring regulatory compliance
Plan and execute Computer System Validation (CSV) and Computer Software Assurance (CSA) activities using risk-based GAMP 5 methodologies
Lead qualification activities for systems, platforms, cloud environments, and sandboxes, including IQ/OQ/PQ
Prepare and review validation documentation such as Validation Plans, Risk Assessments, URS, Functional Specifications, Traceability Matrices, Test Scripts, and Validation Summary Reports
Ensure compliance with GxP, 21 CFR Part 11, EU Annex 11, and applicable pharmaceutical regulatory standards
Requirements
Sr. Engineer, Automation Engineering, Controls Hardware - Lilly Medicine Foundry
The Senior Engineer - Automation Engineering provides automation support for operating areas and capital projects, with a primary focus on Instrumentation and Control Hardware to support new facility start-up and ongoing manufacturing operations.
Compensation
$67,500 - $118,800
Responsibilities
Provide automation support for one or more operating areas across site and/or for capital projects
Collaborate with cross-functional peers to support successful delivery of robust control systems and instrumentation
Support project delivery and startup phases (expected 2026 to 2028)
Develop and implement necessary systems and business processes for GMP operations
Design, Development, and Commissioning Process Automation projects using DeltaV DCS and/or Rockwell Allen Bradley PLC
Lead and execute risk-based IT audits across Sun Pharma's GxP systems, infrastructure, applications, and technology processes, ensuring compliance with regulatory and data integrity requirements.
Responsibilities
Plan and execute risk-based IT audits across Sun Pharma's GxP systems, infrastructure, applications, and technology processes.
Assess compliance with Data Integrity requirements, Computer System Validation (CSV) principles, internal policies, and applicable regulatory expectations including USFDA, MHRA, EMA, and WHO guidelines.
Evaluate IT General Controls (ITGCs) including user access management, segregation of duties, password controls, change management, backup and recovery, business continuity and system documentation life cycle controls.
Review enterprise systems, laboratory systems, manufacturing systems, quality systems, and cloud-based applications for compliance, security, and data integrity risks.
Conduct thorough reviews of audit trails, system logs, electronic records, and user activities to identify process deviations.
Consultant role within TMT Business Consulting Risk, focusing on Digital Risk and Computer System Validation (CSV) for Life Sciences clients.
Responsibilities
Perform assessments of computer systems and processes for Life Sciences clients
Create/ review CSV deliverables like user requirements, system specifications, Validation Plan, Qualification Plans, SOPs, IQ/OQ/PQ, Traceability matrix, Design Specs, and validation summary reports
Provide guidance and oversight of validation activities for projects involving GxP relevant computer systems
Work closely with project team members to incorporate appropriate elements of quality and compliance into the system lifecycle
Review and approve computer system validation work products, assuring thoroughness of validation planning and making appropriate progress towards timely completion of validation deliverables
Consultant role within the Business Consulting Risk department focusing on CHS (Health Sciences & Wellness) and Digital Risk for Consumer Products and Healthcare sectors.
Responsibilities
Perform computer system validation (CSV) across the system lifecycle
Conduct risk assessments and validation documentation
Prepare and execute validation deliverables such as validation plans, URS, FRS, IQ/OQ/PQ protocols, and traceability matrices
Ensure compliance with 21 CFR Part 11 requirements for electronic records, electronic signatures, audit trails, and access controls
Maintain knowledge of GxP-regulated computerized systems
The role focuses on Digital Risk within the Consumer Products and Healthcare (CHS) sectors, specifically involving computer system validation (CSV), GxP compliance, and 21 CFR Part 11 requirements.
Responsibilities
Provide technical excellence in computer system validation (CSV) across the system lifecycle
Perform requirements, risk assessment, testing, and validation documentation
Maintain working knowledge of 21 CFR Part 11 requirements for electronic records and electronic signatures
Prepare and execute validation deliverables such as validation plans, URS, FRS, IQ/OQ/PQ protocols, and traceability matrices
Ensure compliance with GxP-regulated computerized systems
Consultant role focused on Digital Risk within Consumer Products and Health Sciences sectors, requiring computer system validation (CSV) and GxP compliance expertise.
Responsibilities
Computer system validation (CSV) across the system lifecycle
Requirements, risk assessment, testing, and validation documentation
Managing 21 CFR Part 11 requirements for electronic records and signatures
Preparing and executing validation deliverables such as validation plans, URS, FRS, IQ/OQ/PQ protocols, and traceability matrices
Senior Tech Specialist, Cloud EngineeringBrillio · Bangalore, India+1 more
Sr. Engineer, Automation Engineering, Controls Hardware - Lilly Medicine FoundryLilly · Lebanon, US
Manager - Corporate Quality AuditSun Pharmaceutical Industries Ltd