Horizon Controls Group Jobs

Lead CSV Engineer

Horizon Controls Group

Lead CSV Engineer

Posted 16 Days Ago

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Tipperary, IRL

In-Office

Mid level

Consulting • Automation

The Role

Lead CSV Engineer responsible for computer system validation across automation and IT systems. Develop and approve validation deliverables (QAPs, test plans, RTMs), ensure vendor compliance with MSD/GAMP5 standards, provide FAT oversight, create SDLC templates, liaise with stakeholders, and support delivery of validated systems.

Summary Generated by Built In

• Reporting to the Project Manager and CSV Lead, specifically responsible for Computer

System Validation.

• The CSV engineer will be responsible for the development of key quality documents, such as Quality

Assurance (QAPs) test plans, Requirements Traceability Matrices and Quality assurance summary

reports, ensuring adherence to regulatory standards.

• Will be required to work closely with teams responsible for the full Automation and IT

scope and with vendors / partners with responsibility for delivery of systems.

• Will review and ensure vendors compliance with quality standards.

• Will represent the CSV function at Automation, IT and other project meetings, as required.

Successful candidate will be capable of acting as the CSV SME for the project team and providing a

standardized CSV approach across capital projects, as defined by the CSV lead.

• Develop and maintain Qualification Plans and Test Plans, aligned with the overall project C&Q plan

and with the leveraging strategy

• Develop templates for all SDLC deliverables, compliant with MSD standards, to ensure consistent

implementation of the validation strategy, including but not limited to:

o Requirements Specification

o Requirements Traceability Matrix

o Functional Specification

o Design Specification

o Code Review

o Test specification/test script

o Etc.

• Work closely with the Digital Data and Quality (DDQ) function and ensure their requirements are met

in all deliverables

• Approval of all SDLC deliverables, ensuring compliance with standards

• Provide FAT oversight and perform leveraging assessments

• Provide guidance and support to team members tasked with delivery of SDLC

documents

• Provide input to the development of realistic project schedules and document trackers

• Work closely with suppliers / integrators to ensure compliance with MSD standards

• Participate in, and support, relevant project meetings

• Liaise with the various stakeholders on the overall project to ensure clear communication between all

parties in relation to validation requirements

Minimum of 3 years’ experience in a similar role in life sciences, ideally in pharmaceutical

manufacturing.

• Expert knowledge of GAMP5.

• Experience in the following systems is essential; Emerson DeltaV

• Experience in the following systems would be advantageous; DCS, Siemens PLC/SCADA, OSISoft PI, Werum Pax-X

• Excellent computer skills, proficient in the use of the following Microsoft tools: Excel, SharePoint,Word and PowerPoint.

• Strong interpersonal and communication skills (verbal and written).

• Relevant Computer Science or Engineering degree or equivalent

• Previous experience working with paperless validation systems (Kneat) will be advantageous

Get in touch with George at [email protected] if interested in this position.

Skills Required

Minimum of 3 years' experience in CSV or similar role in life sciences/pharmaceutical manufacturing
Expert knowledge of GAMP5
Experience with Emerson DeltaV
Experience with DCS, Siemens PLC/SCADA, OSIsoft PI, Werum Pax-X
Proficiency with Microsoft Excel, SharePoint, Word and PowerPoint
Relevant Computer Science or Engineering degree or equivalent
Previous experience with paperless validation systems (Kneat)
Strong interpersonal and written/verbal communication skills

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The Company

HQ: Plymouth Meeting, PA

72 Employees

Year Founded: 2005

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.