CSV Engineer

PSC Biotech•Pomona, CA

3d•$95,000 - $110,000

About The Position

We are hiring an experienced Computer Systems Validation Engineer. The CSV Engineer will play a critical role in ensuring that all systems are validated and compliant with regulatory standards. This role involves planning, writing, implementing, and executing CSV protocols to ensure that our systems operate as intended and meet all regulatory requirements.

Requirements

Bachelor's degree in Engineering, Computer Science, or a related field.
5 -7 years of computerized system validation experience within the life sciences/pharmaceutical industries.
Strong working knowledge of backend systems, servers, databases, and system infrastructure as they relate to validated environments.
Strong understanding of industry standards and best practices for computer validation such as GAMP 5, 21 CFR Part 11, Annex 11, etc.
Proficiency in data integrity testing and compliance with FDA 21 CFR Part 11 regulations.
Experience with equipment and system integration.
Strong analytical skills with the ability to think critically and solve problems effectively.
Excellent written and verbal communication skills.
Strong time management and organizational abilities.
Detail -oriented mindset with a commitment to maintaining high -quality standards.
Must be authorized to work in the US.
No C2C at this time.

Responsibilities

Collaborate with project stakeholders and cross functional team to define project requirements.
Perform execution of CSV protocols, including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and User Acceptance Testing (UAT).
Generate and execute validation documents and ensure compliance with required GxP and 21 CFR Part 11 regulations.
Participate in the planning, development, and implementation of computer systems validation documentation.
Manage and validate protocols, electronic records, and electronic signatures ensuring data integrity and compliance. Support data and system transfers as needed.
Ensure seamless integration of equipment as required.
Initiate and oversee system CSV associated change control requests and associated validation documentation.
Author, review, and approve scheduled periodic reviews.
Troubleshoot and resolve issues related to validated systems, working closely with internal teams to implement corrective actions.
Additional responsibilities as assigned to drive project success.