Horizon Controls Group have an
exciting opening for a CSV Engineer with one of our major clients in the pharma
industry.
The successful candidate will
join the DDQ team on a site re-structuring project to provide independent
compliance oversight and support for the implementation of new shopfloor
automation systems and modifications to existing site systems. The DDQ
specialist will ensure compliance with regulatory expectations and company
Computer Systems Validation (CSV), System Development Lifecycle (SDLC), Cyber
Security and Data Integrity requirements. The DDQ specialist will support a
number of shopfloor system, including, DeltaV DCS systems, PLC/SCADA systems
and other manufacturing systems.
Responsibilities:
· Providing independent quality
review and approval of system lifecycle documentation, such as plans,
requirements, risk assessments, protocols and reports for new and modified
systems.
· Providing independent quality
review and approval of system changes.
· Supporting and approving
computerised systems investigations and test deviations.
· Ensuring consistent approach to
qualification, change and deviation management across systems being implemented
on the project.
· Providing timely and pro-active
DDQ support and guidance to facilitate project timelines, including close
collaboration with the technical and business units.
· Where required, engaging with
DDQ teams from other sites and capital projects to standardise and align
approach to computerised systems compliance.
Experience:
· Min. 5 years of experience in
QA IT/CSV, CSV and/or a similar role in the pharmaceutical industry.
· Working knowledge of relevant
regulations and industry standards.
· Proven ability to meet
timelines, prioritise tasks and engage with stakeholders.
· Excellent communication skills.
· Project management experience
will be an advantage.
· DeltaV DCS experience
essential.
Skills Required
- Minimum 5 years experience in QA IT/CSV, CSV or similar role in the pharmaceutical industry
- DeltaV DCS experience
- Working knowledge of relevant regulations and industry standards
- Knowledge of Computer Systems Validation (CSV), SDLC, cyber security and data integrity requirements
- Experience supporting PLC/SCADA and other shopfloor/manufacturing systems
- Proven ability to meet timelines, prioritise tasks and engage with stakeholders
- Excellent communication skills
- Project management experience
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.
