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.
FAQs
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