Bachelor's degree in Automation, Controls, Chemical/Electrical Engineering, Computer Science, or related field.
Experience in providing technical direction on automation system architecture in regulated environments.
Familiarity with control system vendor documentation and procurement processes.
Knowledge of data historians, batch reporting systems, and MES.
Experience in leading functional P&ID reviews and managing engineering changes.
Strong grasp of Computer System Validation (CSV) principles and GAMP 5 methodology.
Proven ability to develop and execute C&Q protocols and major CSV deliverables.
Responsibilities
Partner with process engineering to align automation requirements with business needs.
Manage technical changes and provide direction during software development and testing.
Collaborate with the Design Verification Lead to ensure CSV and verification alignment.
Lead the development and execution of C&Q protocols for automation systems.
Create and maintain CSV documentation in compliance with GAMP 5 and company procedures.
Coordinate CSV activities with Quality Assurance and Engineering teams to meet project timelines.
Manage deviations and change controls related to C&Q and CSV activities.
Benefits
Opportunity to work in a dynamic, regulated environment.
Collaboration with cross-functional teams to drive operational excellence.
Professional development through training materials and matrices.
Involvement in high-impact projects within the pharmaceutical and biotech sectors.
Full Job Description
About the Role:
The Computer System Validation (CSV) C&Q Technical Lead for Automation plays a critical role in ensuring that automated systems within the manufacturing environment meet all regulatory and quality standards. This position is responsible for leading the validation and commissioning/qualification (C&Q) activities of computer systems, ensuring compliance with industry regulations such as FDA 21 CFR Part 11 and GxP guidelines. The role involves collaborating closely with cross-functional teams including Quality Assurance, IT, and Engineering to develop and execute validation protocols, risk assessments, and documentation. The Technical Lead will also provide expert guidance on automation system design, implementation, and maintenance to support continuous improvement and operational excellence. Ultimately, this position ensures that all automated systems are validated to guarantee product quality, patient safety, and regulatory compliance throughout the product lifecycle.
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 company 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.
Key Qualifications:
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.
Desired Qualifications:
Prior experience as an Automation Lead or CSV/C&Q Technical Lead on a large-scale pharmaceutical or biotech capital project.
Experience with alarm management strategy and manufacturing execution system (MES) implementation.
Experience supporting regulatory inspections and audits related to automation and computer system validation.
Soft Skills:
Adaptability: working effectively under a dynamic project schedule
Leadership: providing technical direction across multi-disciplinary teams
Organization and attention to detail
Communication: clearly conveying CSV strategy expectations and progress to stakeholders and clients
