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.
About the Role
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.
Key Responsibilities
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
Required Experience & Skills
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
Desirable (Nice to Have)
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
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