CSV Computer System Validation Engineer II supporting protocol execution for laboratory computer systems in a GxP manufacturing site.
Responsibilities
Execute approved CSV protocols and test scripts for laboratory computer systems in accordance with site procedures, project schedules, and GxP requirements.
Support validation activities for laboratory systems such as LIMS, CDS, ELN, SDMS, standalone instruments, instrument workstations, and related data acquisition or reporting applications.
Document test results clearly and accurately, including objective evidence, screenshots, printouts, attachments, and traceability to approved requirements.
Identify, document, and elevate protocol discrepancies, test failures, and deviations in accordance with site quality procedures.
Perform verification of user access, audit trails, electronic records, electronic signatures, data integrity controls, backup/restore, and other applicable Part 11 and Annex 11 requirements.
Perform work in compliance with PM Group’s Service Delivery Platforms and Quality Management System, interact with clients and internal teams, prepare technical documents, and perform CQV testing.
Compensation
The pay range for this position is $75,000 – $90,000 annually.
Responsibilities
Perform work in compliance with PM Group’s Service Delivery Platforms and Quality Management System
Interact and communicate with the CQV department, other departments, project team members, clients and other external parties to ensure co-ordination of activities
Liaise with senior colleagues and mentors as appropriate
Keep abreast of current technology, regulatory and industry standards
Demonstrate a knowledge of PM Group and / industry standard methodologies and tools for CQV and GMP
Requirements
Bachelor’s degree in Engineering or Science
Nice to have: previous Co-op or Internship with pharmaceutical industry experience
The Engineer - Automation Engineering provides automation support for operating areas and capital projects at the Lilly Medicine Foundry, focusing on technical leadership, mentorship, and the implementation of compliant control applications to support GMP manufacturing operations.
Compensation
$67,500 - $99,000 plus company bonus
Responsibilities
Mentor process control team, including design, controls philosophy, implementation and commissioning
Process control work implementation and coordination
Develop and implement the Automation Engineering Project Plan
Technically lead and oversee the work of Site Area leads and System Integrator including Functional Requirements, Design Specifications, DCS Application Software, Test Specifications
Lead/ Participate in design reviews and DeltaV application software reviews, attend equipment and software FATs
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.
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