What are the responsibilities and job description for the Automation Engineer - CSV position at PM Group?
Overview
PM Group is seeking a CSV Automation Engineer to join our growing Life Sciences team. In this role, you’ll ensure compliance, reliability, and data integrity across GxP-regulated computerized and automation systems throughout their lifecycle. You will play an essential part in supporting our clients’ pharmaceutical and biotechnology manufacturing operations by integrating automation, validation, and quality principles into every stage of project delivery.
Responsibilities
Key Responsibilities:
Why Join PM Group
PM Group is an employee-owned, international project delivery company with a team of over 4,000 professionals across 18 offices worldwide. We deliver complex capital projects for leading clients in the pharmaceutical, biotechnology, food, and advanced manufacturing sectors.
At PM Group, you’ll work in a collaborative, innovative environment where your expertise contributes directly to projects that improve lives around the world. We offer a culture of continuous learning, global career mobility, and meaningful opportunities for professional growth.
PM Group is seeking a CSV Automation Engineer to join our growing Life Sciences team. In this role, you’ll ensure compliance, reliability, and data integrity across GxP-regulated computerized and automation systems throughout their lifecycle. You will play an essential part in supporting our clients’ pharmaceutical and biotechnology manufacturing operations by integrating automation, validation, and quality principles into every stage of project delivery.
Responsibilities
Key Responsibilities:
- Support validation activities for computerized and automation systems in regulated manufacturing environments.
- Review and approve automation documentation, including DeltaV, PAS-X MES, OSI PI, and Honeywell BAS software FATs, SATs, and qualification protocols.
- Develop, execute, and maintain validation processes in alignment with 21 CFR Part 11, Annex 11, and GAMP 5 guidelines.
- Collaborate closely with Automation, Quality, and Commissioning teams to ensure accurate impact assessments and adherence to GMP standards.
- Lead and manage validation documentation using electronic systems such as Kneat.
- Support the development of user requirement specifications (URS), validation plans, risk and impact assessments, and traceability matrices.
- Provide data integrity oversight and ensure ongoing compliance across computerized and automation systems.
- Participate in audits, commissioning, and qualification (C&Q) activities related to CSV and automation systems.
- Bachelor’s degree in Automation, Electrical Engineering, Computer Science, or a related technical discipline.
- Minimum 2 years of relevant experience, including at least 1 year in Computer System Validation (CSV) within a regulated environment.
- Strong understanding of automation control systems, manufacturing IT systems, and regulatory compliance standards (21 CFR Part 11, Annex 11, GAMP 5).
- Experience with Honeywell BAS, DeltaV, PAS-X, OSI PI, or similar platforms preferred.
- Familiarity with Siemens PLCs and Kneat e-validation tools is a plus.
- Excellent communication, organization, and documentation skills, with the ability to work effectively in cross-functional teams.
Why Join PM Group
PM Group is an employee-owned, international project delivery company with a team of over 4,000 professionals across 18 offices worldwide. We deliver complex capital projects for leading clients in the pharmaceutical, biotechnology, food, and advanced manufacturing sectors.
At PM Group, you’ll work in a collaborative, innovative environment where your expertise contributes directly to projects that improve lives around the world. We offer a culture of continuous learning, global career mobility, and meaningful opportunities for professional growth.