Job Summary
We are seeking a Computer System Validation
(CSV) Engineer to support the validation and lifecycle management of GxP
computer systems in our manufacturing and laboratory environments. This role is
critical in ensuring regulatory compliance, data integrity, and consistent
performance of computerised systems in accordance with FDA, EMA, GAMP 5, and
other relevant regulations and guidelines.
Key
Responsibilities
- Plan,
develop, execute, and document CSV activities in accordance with internal
procedures and regulatory requirements.
- Author
and review validation documentation such as Validation Plans, User
Requirements Specifications (URS), Risk Assessments, IQ/OQ/PQ Protocols,
and Reports.
- Ensure
compliance with 21 CFR Part 11, EU Annex 11, and other relevant global
regulatory guidelines.
- Collaborate
with cross-functional teams including IT, Quality Assurance,
Manufacturing, and Engineering to implement validated systems.
- Support
audits and inspections by regulatory authorities and internal teams.
- Perform
periodic reviews, change control assessments, and re-validation
activities.
- Participate
in project teams for new system implementations and upgrades.
- Provide
training and guidance on CSV processes and best practices to internal
stakeholders.
Requirements
Qualifications
Required:
- Bachelor’s
or Master’s degree in Engineering, Computer Science, Life Sciences, or
related field.
- Minimum
of 3–5 years of experience in CSV within the pharmaceutical, biotech, or
life sciences industry.
- Strong
understanding of GxP regulations, GAMP 5, data integrity principles, and
validation lifecycle.
- Experience
with systems such as LIMS, MES, ERP, SCADA, or laboratory equipment with
software components.
- Proficient
in English; German language skills are a strong advantage.
- Job is
remote with some occasional travel to Germany when needed.
- Experience
in an international pharmaceutical environment.
- Familiarity
with Agile or V-model methodologies.
- Knowledge
of cybersecurity principles as they relate to validated systems.
- Ability
to manage multiple validation projects in parallel.
Skills Required
- Bachelor's or Master's degree in Engineering, Computer Science, Life Sciences, or related field.
- Minimum of 3-5 years of experience in CSV within the pharmaceutical, biotech, or life sciences industry.
- Strong understanding of GxP regulations, GAMP 5, data integrity principles, and validation lifecycle.
- Experience with systems such as LIMS, MES, ERP, SCADA, or laboratory equipment with software components.
- Proficient in English.
- German language skills.
- Remote role with occasional travel to Germany when needed (ability to travel).
- Experience in an international pharmaceutical environment.
- Familiarity with Agile or V-model methodologies.
- Knowledge of cybersecurity principles as they relate to validated systems.
- Ability to manage multiple validation projects in parallel.
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.
