Overview
We are seeking an experienced and results-driven CSV (Computer System Validation) Engineer to join our dynamic team. As a CSV Engineer, you will play a vital role in ensuring the compliance, qualification, and validation of computerized systems in a regulated environment, contributing directly to the quality and reliability of our manufacturing and laboratory operations. You will collaborate across departments such as Quality Assurance, IT, Engineering, and Production to deliver robust and compliant solutions in line with industry standards and best practices.
Key Responsibilities
* Lead and execute the validation lifecycle for computerized systems including planning, risk assessments, requirement specifications, testing, reporting, and change management.
* Write and review documentation such as validation protocols (IQ/OQ/PQ), risk assessments, user requirements, system specifications, URS, and validation reports.
* Ensure compliance with regulatory requirements (e.g., FDA 21 CFR Part 11, EU Annex 11, GAMP5) and internal quality standards throughout system design, implementation, and operation.
* Serve as the SME (Subject Matter Expert) for CSV topics, providing guidance and training to project teams and end-users on validation processes and documentation.
* Participate in audits and inspections as the CSV representative, addressing questions and findings related to computerized system validation.
* Collaborate with cross-functional teams to integrate CSV activities into project timelines and deliverables, ensuring systems are fit-for-purpose and compliant at all stages.
* Identify opportunities for process improvement in validation strategies and contribute to the implementation of automation or digitalization projects within the organization.
* Support incident/problem management and perform impact assessments for changes to qualified systems.
Qualifications
* Bachelor’s or Master’s degree in Engineering, Computer Science, Life Sciences, or related field.
* Proven work experience (typically 2+ years) in CSV within a regulated (e.g., pharmaceutical, biotechnology or medical device) industry.
* Strong knowledge of GMP, GAMP5, and applicable regulatory requirements for electronic records and signatures.
* Experience in writing and executing validation protocols, with a systematic and detail-oriented approach.
* Strong analytical thinking, problem-solving, and documentation skills.
* Excellent communication skills in English, both written and verbal; ability to interact with various stakeholders and departments.
* Experience with MES, LIMS, DCS, PLC, or other automation/control systems is an advantage.
What We Offer
* A challenging and diverse role in a highly regulated and innovative environment.
* Opportunities for professional growth and continued learning.
* The chance to be part of impactful projects that contribute to public health and safety.
Job Details
* Seniority level: Associate
* Employment type: Full-time
* Job function: Quality Assurance, Science, and Production
* Industries: Pharmaceutical Manufacturing
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