We are seeking an experienced Senior CSV Engineer to support a major pharmaceutical manufacturing and capital project environment. The successful candidate will take a lead role in the validation and compliance of computerised systems, ensuring systems are implemented and maintained in accordance with GMP, GAMP 5, data integrity requirements, and applicable regulatory standards.
This is a senior-level position suited to a CSV professional with strong experience working within pharmaceutical, biotechnology, or other highly regulated manufacturing environments.
Lead and execute Computer System Validation (CSV) activities across manufacturing, laboratory, automation, engineering, and business systems.
Develop, review, and approve validation documentation including:
Validation Plans
User Requirements Specifications (URS)
Functional and Design Specifications
Risk Assessments
Configuration Specifications
IQ/OQ/PQ protocols
Traceability Matrices
Validation Summary Reports
Apply a risk-based validation approach in accordance with GAMP 5 and site procedures.
Ensure computerised systems comply with applicable GMP, data integrity, electronic records and electronic signature requirements, including 21 CFR Part 11 and EU Annex 11 where applicable.
Work closely with Engineering, Automation, IT, Quality, Operations, Laboratory and equipment vendors throughout the system lifecycle.
Review system architecture, configurations, software functionality, interfaces and data flows from a validation and compliance perspective.
Support the validation of systems such as DCS, PLC/SCADA, MES, historian, laboratory, utility, manufacturing and other GxP computerised systems.
Lead or support execution of validation testing, deviation resolution and defect management.
Perform and document GxP system risk assessments and determine appropriate validation controls.
Support commissioning and qualification activities where computerised systems interface with process equipment.
Manage validation deliverables from third-party vendors and system integrators.
Support change controls, deviations, CAPAs, periodic reviews and system lifecycle activities.
Participate in regulatory inspections, internal audits and quality reviews as the CSV subject matter expert.
Provide technical guidance and mentoring to junior CSV or validation engineers.
Drive continuous improvement in CSV processes, templates and validation methodologies while maintaining regulatory compliance.
Degree in Engineering, Computer Science, Automation, Science, Information Technology or a related technical discipline.
Typically 5–8+ years' experience in Computer System Validation, preferably within pharmaceutical, biotechnology or regulated manufacturing.
Strong working knowledge of GAMP 5 and risk-based computer system validation.
Good understanding of EU GMP Annex 11, 21 CFR Part 11 and data integrity principles such as ALCOA+.
Demonstrated experience generating and executing CSV lifecycle documentation.
Experience with GxP manufacturing or laboratory computerised systems.
Strong understanding of validation lifecycle management, change control, deviation management and quality systems.
Experience working with automation platforms, manufacturing systems or laboratory systems would be highly advantageous.
Ability to review technical documentation and translate regulatory requirements into practical validation strategies.
Strong stakeholder management and communication skills, with the ability to work effectively across Quality, Engineering, Automation, IT and Operations teams.
Comfortable operating independently and taking ownership of validation workstreams within complex projects.
Experience in one or more of the following would be advantageous:
DeltaV or other DCS platforms
PLC / SCADA systems
MES
OSIsoft PI / process historians
LIMS or laboratory systems
Building Management Systems (BMS)
Environmental Monitoring Systems
Serialization or packaging systems
ERP / SAP systems
Data integrity assessments
Automation or equipment qualification
Pharmaceutical capital projects, facility expansions or technology transfer projects
This position offers the opportunity to work on technically complex pharmaceutical manufacturing and digital systems projects within a highly regulated GMP environment. The Senior CSV Engineer will have significant responsibility for validation strategy, execution and compliance, while working alongside multidisciplinary engineering, automation, quality and manufacturing teams.
Skills Required
- Degree in Engineering, Computer Science, Automation, Science, Information Technology, or a related technical discipline
- 5–8+ years of experience in Computer System Validation, preferably in pharmaceutical, biotechnology, or regulated manufacturing environments
- Strong working knowledge of GAMP 5 and risk-based computer system validation
- Understanding of EU GMP Annex 11, 21 CFR Part 11, and ALCOA+ data integrity principles
- Experience generating and executing CSV lifecycle documentation
- Experience with GxP manufacturing or laboratory computerized systems
- Understanding of validation lifecycle management, change control, deviation management, and quality systems
- Ability to review technical documentation and translate regulatory requirements into practical validation strategies
- Strong stakeholder management and communication skills across Quality, Engineering, Automation, IT, and Operations teams
- Ability to work independently and own validation workstreams within complex projects
- Experience with automation platforms, manufacturing systems, or laboratory systems
- Experience with DeltaV or other DCS platforms
- Experience with PLC or SCADA systems
- Experience with MES
- Experience with OSIsoft PI or process historians
- Experience with LIMS or laboratory systems
- Experience with Building Management Systems or Environmental Monitoring Systems
- Experience with serialization, packaging, ERP, or SAP systems
- Experience with data integrity assessments, automation or equipment qualification, pharmaceutical capital projects, facility expansions, or technology transfer projects
What We Do
Horizon Controls Group: A global leader in automation consulting, enabling both clients and employees to live on the forefront of evolving technology. Horizon Controls Group is a modern, global technology company, specializing in automation consulting, engineering, and training. Founded on the belief that our people are the difference, we have grown entirely from customer references and successive projects. Our people and their established reputation are our most valued assets. This belief has created a great place to work, enabling us to attract the very best and to give our customers confidence in our superior solutions. Our business is comprised of excellence at every level. We employ a pro-active and comprehensive approach to projects -- asking the right questions, analyzing client needs, and engineering a skilled solution. We are committed to understanding the entire spectrum of your automation challenges and to developing uniquely tailored innovative solutions. Our decision to be vendor-independent enables us to offer tailored solutions and represent your needs free of any conflict of interest. We are aligned exclusively with our customers' goals and system requirements, enabling us to provide maximum value. Ultimately, the ability to harvest maximum value from new systems is dependent on the quality and training of your people. Just as we expect and ensure absolute expertise in our people, we work with you to ensure your team is trained to the specific needs of your organization and remain at the forefront of industry trends. We are a global company operating in the United States from our headquarters in Blue Bell, PA and offices in Indiana, Massachusetts, North Carolina, and California and from Cork in Ireland. This is Horizon Controls Group’s official company LinkedIn page.
