Horizon Controls Group are looking to hire an experienced Automation Computer System Validation (CSV) Engineer to support pharmaceutical manufacturing systems within a regulated GMP environment. This role is ideal for a validation professional with strong automation exposure who enjoys working at the intersection of compliance, technology, and operations.
The Automation CSV Engineer will be responsible for ensuring that automated control systems are validated and maintained in compliance with regulatory requirements and industry best practices. You will work closely with automation engineers, quality, IT, and manufacturing teams to deliver compliant and inspection-ready systems.
Lead and support CSV activities for automation and control systems
Develop, review, and execute validation documentation including URS, FRS, HDS, SDS, RA, IQ, OQ, PQ
Ensure compliance with GAMP 5, GMP, and 21 CFR Part 11 / Annex 11
Support validation of DeltaV DCS, PLC, SCADA, and associated systems
Participate in FAT and SAT activities from a CSV perspective
Perform risk assessments and define validation strategies for new and existing systems
Support audits and regulatory inspections (HPRA, FDA, EMA)
Manage change control, periodic reviews, and system lifecycle documentation
Collaborate with automation, quality, IT, and vendor teams
Proven experience as a CSV Engineer within pharmaceutical or life sciences manufacturing
Strong understanding of automation systems validation
Hands-on experience with validation of DCS / PLC / SCADA systems
In-depth knowledge of GMP, GAMP 5, and data integrity principles
Experience working with 21 CFR Part 11 / EU Annex 11 requirements
Excellent documentation and reporting skills
Strong stakeholder engagement and communication abilities
Experience validating Emerson DeltaV systems
Exposure to MES, Historian, or laboratory systems
Experience supporting site expansions, system upgrades, or remediation projects
Familiarity with data integrity assessments and cybersecurity considerations
Skills Required
- Proven experience as a CSV Engineer within pharmaceutical or life sciences manufacturing
- Strong understanding of automation systems validation
- Hands-on experience with validation of DCS / PLC / SCADA systems
- In-depth knowledge of GMP, GAMP 5, and data integrity principles
- Experience working with 21 CFR Part 11 / EU Annex 11 requirements
- Excellent documentation and reporting skills
- Strong stakeholder engagement and communication abilities
- Experience supporting audits and regulatory inspections (HPRA, FDA, EMA)
- Experience validating Emerson DeltaV systems
- Exposure to MES, Historian, or laboratory systems
- Experience supporting site expansions, system upgrades, or remediation projects
- Familiarity with data integrity assessments and cybersecurity considerations
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.
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