Overview
Sr. Engineer, QA Validation Jobs in Novato, California, USA at Initial Therapeutics, Inc.
Senior engineer, CSA and Process Automation QA Oversight Role
This position is responsible for Quality Assurance Validation (QAV) oversight of Computer Systems and Analytical instruments Validation, and the associated systems lifecycle management activities.
This role offers a diverse breadth of accountability spanning validation of Computer Systems, GxP software applications, manufacturing, QC, and Bio-Analytical instruments, and process automation systems. The individual will work closely with Information Management (IM), Engineering, Regulatory, Manufacturing, QC, site QA, guiding the planning and design phase of projects and continuous process improvements in manufacturing and lab environments. Supporting partners in identifying and navigating risk-appropriate qualification strategies is critical for success.
This position requires broad knowledge and experience with biologic processes, quality engineering, validation, and an understanding of the international regulatory landscape.
Experience with applications such as Delta
V, PI, SCADA, Version dog is preferred.
Bio Marin’s Technical Operations group is responsible for creating drugs for clinical trials and scaling production for the market. They build and maintain manufacturing processes and sites, ensure quality assurance and control, and support the worldwide distribution of our drugs.
Key Responsibilities
Provide QA oversight for Computer System Validation (CSV), manufacturing, QC, and Bio-Analytical Instruments to ensure compliance and quality.
Drive Computer Software Assurance (CSA) including risk assessments, gap analysis, and system lifecycle management.
Guide and oversee SDLC documents like User Requirements, Functional & Software Specifications, Validation/Qualification protocols, and test scripts.
Support Quality Change Management activities related to new and existing validated computer systems.
Investigate and perform root cause analysis on CSV discrepancies and quality records (deviations, CAPAs).
Author and develop Periodic Review Reports for computerized systems.
Represent QAV in meetings and project teams, coordinating validation activities across departments.
Support and oversee Bio Marin’s Data Integrity Program.
Contribute to CSV strategies and long-term roadmaps.
Maintain knowledge of industry standards and regulations, including FDA and EU guidelines.
Participate in audits, provide assessments, and support regulatory inspections.
Lead resources to manage CSV activities, including hiring, training, contract management, and budgeting.
Develop and report on project metrics.
Education
/ Experience
BS in IT/IM/Computer Science, Engineering, or equivalent experience.
8-10 years’ experience in CSV within the life sciences or regulated industry.
3-5 years’ experience in analytical instruments validation.
Experience in biotech or pharma quality areas, deviations, CAPAs, change control, and industry regulations.
Knowledge of Data Integrity requirements and industry standards.
Experience with Veeva QMS, Analytical instruments, PI, SCADA, Delta
V, ALM.
Shift Details & Location
Days, with support for off-shift work as needed. Hybrid model with at least 2 days onsite in Novato. Some travel for conferences and initiatives may be required.
Note:
This description is not exhaustive and may include other duties. Equal Opportunity Employer/Veterans/Disabled.
#J-18808-Ljbffr
Title: Sr. Engineer, QA Validation
Company: Initial Therapeutics, Inc.
Location: Novato, California, USA
Category: Quality Assurance – QA/QC (Data Analyst), Engineering
