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PM Group · 6 days ago

Automation Engineer - CSV

Apex, NC

Full-time

Onsite

Entry, Mid Level

2+ years exp

PM Group is an employee-owned, international project delivery company seeking a CSV Automation Engineer to join their Life Sciences team. The role involves ensuring compliance, reliability, and data integrity across GxP-regulated computerized and automation systems throughout their lifecycle, supporting clients' pharmaceutical and biotechnology manufacturing operations.

Architecture

Growth Opportunities

H1B Sponsor Likely

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

Qualification

Computer System Validation (CSV)Automation control systemsRegulatory compliance standardsHoneywell BASDeltaVPAS-XOSI PISiemens PLCsKneat e-validation toolsCommunication skillsOrganization skillsDocumentation skills

Required

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)

Excellent communication, organization, and documentation skills, with the ability to work effectively in cross-functional teams

Preferred

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

Company

PM Group

Glassdoor4.3

PM Group is an international project delivery firm providing professional services in architecture, engineering and construction.

Founded in 1973

Diegem, Vlaams-Brabant, BEL

1001-5000 employees

http://www.pmgroup-global.com/

H1B Sponsorship

PM Group has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (2)

2023 (3)

2021 (1)