CSV Engineer

A well-established engineering consultancy is seeking a skilled professional to support projects within the pharmaceutical and biotechnology industries. With a presence across North America and Asia, the organization contributes to a wide range of facility design, process engineering, automation, and quality system initiatives for global life sciences clients. Position Overview: The successful candidate will join a multidisciplinary team focused on the design, automation, commissioning, and startup of manufacturing systems and processes. This role requires a blend of engineering expertise, automation experience, and strong technical writing capabilities. Key Responsibilities: Develop and maintain documentation to support robust validation practices aligned with industry standards. Prepare and execute validation protocols (URS, IQ, OQ, PQ) in accordance with Good Documentation Practices (GDP). Design validation strategies using statistical methods; coordinate and perform validation activities; analyze results and compile comprehensive reports. Conduct data integrity assessments and ensure systems comply with 21 CFR Part 11. Collaborate with equipment vendors to ensure user and functional requirements are met; draft supporting documentation. Assist cross-functional teams, including R&D and manufacturing, to facilitate technology transfer and process improvements. Manage assigned tasks proactively, communicating delays or issues to project stakeholders. Review automation software (e.g., DeltaV) and develop test protocols based on system specifications. Adhere to all applicable regulatory, corporate, and quality system requirements. Qualifications: Bachelor's or Master's degree in engineering or a related field. Minimum of 4 years of experience in an FDA-regulated environment; experience with upstream/downstream equipment is a plus. At least 2 years of hands-on experience with DeltaV, including protocol development and software interaction. Familiarity with engineering documentation (URS, FRS, DS) and validation lifecycle (IQ, OQ, PQ, CSV, MVP). Strong understanding of computer systems validation and quality systems (change control, non-conformance, requalification). Proficiency in Microsoft Office tools (Word, Excel, PowerPoint). Ability to work independently, manage multiple projects, and collaborate effectively. Excellent communication, interpersonal, and technical writing skills. Job Details

Seniority level: Entry level Employment type: Full-time Job function: Automation Machinery Manufacturing

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