CSV C&Q Technical Lead

The CSV C&Q Technical Lead is responsible for defining, developing and delivering the CSV requirements, documentation and technical input needed by the C&Q program throughout its lifecycle - from Design and documentation preparation through FAT, CM oversight, MC, integrated execution and handover to the Client USER team., The scope of CSV activities relates to the computerized systems and automation supporting Process and Process Support Equipment. The CSV SME owns the development, review and approval of CSV requirements, test plans, specifications and documentation, working closely with CQV leads/specialists, engineers, operations personnel, engineering and external vendors, contractors, sub-contractors including the automation integrator and CSV service provider(s).

Aside to delivering in line with the Client C+Q requirements, the CSV Lead will ensure that CSV-specific Compliance, Quality and HSE objectives are achieved in line with the overall Project Budget and Baseline Schedule. The CSV Lead will form part of the Client core team, attending core team meetings, providing CSV requirements and guidance at each project phase and representing PDP in terms of CSV-related contractual obligations.

Following are the summary of this role responsibilities:

• Partner with process engineering to ensure automation requirements are aligned with business needs.
• Manage technical changes and provide technical direction through all software development and testing activities.
• Partner with the Design Verification Lead to ensure alignment between CSV and verification expectations.
• Provide direction for CSV strategy, validation approach, and major CSV deliverables (Requirements, Design, Security Plan, Test Plan, etc.).
• Lead development and execution of Commissioning and Qualification (C&Q) protocols (IQ/OQ/PQ) for automation and control systems.
• Develop all related CSV documentation (validation plans, requirements traceability matrices, test scripts, summary reports) ensuring it complies with GAMP 5 and applicable specifications and Lilly quality system procedures.
• Coordinate CSV activities with Quality Assurance, Automation Engineering, and Commissioning teams to support project schedule and data integrity requirements.
• Manage deviations, discrepancies, and change controls associated with C&Q and CSV activities.
• Develop and maintain CSV training materials and matrices for the CSV team, automation integrator, CSV service provider, and Client USER groups.
• Support FAT/SAT execution and assist with system handover to the Client USER team.
• Provide CSV input to the C&Q schedule and progress reporting, including system definition/classification and baseline CSV milestones.

• Bachelor’s degree in Automation, Controls, Chemical/Electrical Engineering, Computer Science, or a related field, or an equivalent combination of education and relevant experience.
• Demonstrated experience providing technical direction on automation system architecture, hardware/software platforms, and programming standards within a pharmaceutical, biotech, or comparable regulated capital-project environment.
• Experience reviewing control system and packaged equipment vendor documentation and supporting automation hardware, software, and licensing procurement.
• Working knowledge of data historians, batch reporting systems, and manufacturing execution systems (MES).
• Experience performing functional P&ID reviews, leading prototyping activities, and managing technical/engineering changes.
• Strong understanding of Computer System Validation (CSV) principles, GAMP 5 methodology, and data integrity (ALCOA+) requirements.
• Experience developing and executing C&Q protocols (IQ/OQ/PQ) and major CSV deliverables, including validation plans, requirements traceability matrices, test scripts, and summary reports.
• Ability to partner effectively with Design Verification, Process Engineering, Quality Assurance, and Commissioning teams.
• Strong organizational, communication, and leadership skills to drive technical direction across multi-disciplinary teams under a dynamic project schedule.

ADDITIONAL SKILLS

• Prior experience as an Automation Lead or CSV/C&Q Technical Lead on a large-scale pharmaceutical or biotech capital project.
• Familiarity with Client’s systems, guidelines, and quality procedures.
• Experience with alarm management strategy and manufacturing execution system (MES) implementation.
• Experience supporting regulatory inspections and audits related to automation and computer system validation.

JC Automation Corp. (JCA) was founded in 1997 with the mission of filling a gap between technology and regulatory requirements in the life science manufacturing industry. The company offers highly capable resources at an affordable cost to build solutions and execute projects in: Automation, Control Systems Integration, Information Technology, System Integration and Regulatory Compliance.

JCA is a HUBZone Certified Small Business Firm, NMSDC Certified Minority Business Enterprise, and Certified Critical Industry Supplier. It’s mission is to add value by delivering quality services & solutions on time all the time by transforming processes & technology into business advantages.