What are the responsibilities and job description for the CSV Engineer III position at PM Group?
Overview
The CSV Engineer III position is an exciting opportunity to join PM Group’s quickly growing Philadelphia-area Outsourced Technical Services (OTS) team. Outsourced Technical Services (OTS) is an integral part of PM Group’s ability to support clients across the complete project life cycle. With over 50 years of industry experience, strong technical knowledge, and integrated resources, clients look to us to provide experienced technical professionals who complement their project teams.
Together, we are sharing knowledge, learning, growing, and continuing to be an integral part of PM Group’s ongoing expansion in the US.
This is a mid-level career role for a professional who enjoys both client interaction and the technical demands of Computer System Validation. The position requires a strong understanding of the full CSV lifecycle, including validation planning, risk assessments, requirements development, testing documentation, execution, and data integrity compliance.
The CSV Engineer III will be expected to manage multiple active projects while maintaining strong documentation discipline, collaboration skills, and a client-focused mindset. A solid understanding of 21 CFR Part 11, Annex 11, data integrity guidelines, and Good Documentation Practices (GDP) is essential.
You will be mentored by senior CSV team members, provide guidance to junior staff, and report directly to the Director of CSV. Responsibilities include authoring validation documents, supporting system implementation teams, and executing validation testing to meet client needs. Project work will span all phases of the validation lifecycle, and periodic travel to client sites is required.
PM Group is an employee owned, international project delivery firm with a team of 4,000 people. We are world leaders in the pharma, food, biotech, medical technology and mission critical sectors. From our network of offices in Europe, Asia and the US, we work with the world's leading organizations. We are focused on growing a sustainable business centered on our people, our clients and trade partners.
Responsibilities
Why PM Group?
As an employee-owned company, we are inclusive, committed and driven. Corporate Responsibility and Sustainability are the heart of our new 2025 business strategy. Click here to read more in our 2024 Environmental, Social and Governance Report.
Inclusion and Diversity are core to our culture and values. Wherever we work, we commit to a culture of mutual respect and belonging by building a truly inclusive workplace rich in diverse people, talents and ideas. Valuing the contributions of all our people and respecting individual differences will sustain our growth into the future.
PM Group is committed to ensuring our hiring process is fair and accessible to all and will provide candidates with disabilities with reasonable accommodations required to participate in the recruitment process. If you require any assistance in this regard, please let us know.
RECRUITMENT AGENCIES NEED NOT APPLY
The CSV Engineer III position is an exciting opportunity to join PM Group’s quickly growing Philadelphia-area Outsourced Technical Services (OTS) team. Outsourced Technical Services (OTS) is an integral part of PM Group’s ability to support clients across the complete project life cycle. With over 50 years of industry experience, strong technical knowledge, and integrated resources, clients look to us to provide experienced technical professionals who complement their project teams.
Together, we are sharing knowledge, learning, growing, and continuing to be an integral part of PM Group’s ongoing expansion in the US.
This is a mid-level career role for a professional who enjoys both client interaction and the technical demands of Computer System Validation. The position requires a strong understanding of the full CSV lifecycle, including validation planning, risk assessments, requirements development, testing documentation, execution, and data integrity compliance.
The CSV Engineer III will be expected to manage multiple active projects while maintaining strong documentation discipline, collaboration skills, and a client-focused mindset. A solid understanding of 21 CFR Part 11, Annex 11, data integrity guidelines, and Good Documentation Practices (GDP) is essential.
You will be mentored by senior CSV team members, provide guidance to junior staff, and report directly to the Director of CSV. Responsibilities include authoring validation documents, supporting system implementation teams, and executing validation testing to meet client needs. Project work will span all phases of the validation lifecycle, and periodic travel to client sites is required.
PM Group is an employee owned, international project delivery firm with a team of 4,000 people. We are world leaders in the pharma, food, biotech, medical technology and mission critical sectors. From our network of offices in Europe, Asia and the US, we work with the world's leading organizations. We are focused on growing a sustainable business centered on our people, our clients and trade partners.
Responsibilities
- Perform work in alignment with PM Group’s Service Delivery Platforms and Quality Management System (QMS)
- Independently engage with clients to assess and continuously re-evaluate CSV needs
- Perform system-level and process-level data integrity and compliance gap assessments
- Author validation deliverables including URS, FRS, Risk Assessments, Validation Plans, Test Protocols (IQ/OQ/PQ), Traceability Matrices, and Final Reports
- Demonstrate an understanding of the scope of assigned systems and projects
- Demonstrate awareness of commercial aspects including project hours and capital cost considerations
- Deliver assigned validation scope within agreed-upon budget and timelines
- Develop and execute test scripts in compliance with client and regulatory expectations
- Apply Good Documentation Practices (GDP) in all work products
- Collaborate within multidisciplinary teams including IT, Quality, Engineering, and Operations
- Execute validation testing and peer review CSV documents from other team members
- Ensure implementation and maintenance of compliance with cGMP and data integrity requirements
- Independently assess which systems require validation, revalidation, or periodic review
- Provide technical guidance to less experienced CSV team members
- Participate in special projects as assigned
- Support change control, deviation resolution, and system lifecycle management activities
- Review vendor-supplied documents including specifications, configuration documents, and software release materials
- Bachelor’s degree required; engineering, computer science, or related technical discipline preferred
- 5–10 years of Computer System Validation (CSV) experience within Pharmaceutical, Biotech, Life Sciences, or Cell & Gene Therapy industries
- Experience with validation of GxP computerized systems, including laboratory systems, manufacturing systems, quality systems, or IT infrastructure components
- Hands-on experience with risk-based validation methodologies (GAMP 5)
- Experience working with 21 CFR Part 11, EU Annex 11, data integrity guidance, and computerized system lifecycle principles
- Ability to support development of User Requirements Specifications (URS) and System Impact Assessments (SIA)
- Demonstrated experience working in regulated life sciences environments
- Active participant in document review and approval workflows
- Understanding of full validation lifecycle and change control processes
- Experience reviewing vendor documentation including system specifications, release notes, and configuration guides
- Familiarity with system architecture diagrams and basic understanding of IT/OT system design
- Strong understanding of validation planning, testing methodologies, and documentation standards
- Excellent technical writing skills are mandatory
- Ability to travel as needed for client support and project execution
- Knowledge of cGMP environments and regulatory expectations is required
- Ability to work both independently and collaboratively in a fast-paced project environment
Why PM Group?
As an employee-owned company, we are inclusive, committed and driven. Corporate Responsibility and Sustainability are the heart of our new 2025 business strategy. Click here to read more in our 2024 Environmental, Social and Governance Report.
Inclusion and Diversity are core to our culture and values. Wherever we work, we commit to a culture of mutual respect and belonging by building a truly inclusive workplace rich in diverse people, talents and ideas. Valuing the contributions of all our people and respecting individual differences will sustain our growth into the future.
PM Group is committed to ensuring our hiring process is fair and accessible to all and will provide candidates with disabilities with reasonable accommodations required to participate in the recruitment process. If you require any assistance in this regard, please let us know.
RECRUITMENT AGENCIES NEED NOT APPLY