Department: Azzur Labs, LLC
Azzur Group is currently seeking a Senior CSV Engineer who will write, review, and implement GXP-compliant computer software validation solutions in a regulated laboratory environment. This individual will collaborate with global quality, operations, and IT teams to ensure all regulatory requirements are met for all systems within the nationwide business network.
- Design, write, review, and implement validation SOPs and documentation required to ensure CSV compliance for all lab instruments and/or management systems.
- Review and analyze systems validation data and compile summary reports where required.
- Train other staff members on the correct use of computerized systems in line with protocol and regulations.
- Implements and maintains higher-level quality systems that govern data integrity and validation of computer systems used to perform GxP testing.
- Ensures compliance to FDA 21 CFR Part 11 using the GAMP lifecycle framework. Additional compliance experience required: EU Annex 11, PIC/S Guide, CFR 820, CFR 210, and CFR 211.
- Possesses the knowledge and ability to conduct client audits in a professional, ethical, and objective manner both while on-site and follow- up correspondence and audit responses.
- Collaborates with the implementation, maintenance, and improvement of quality systems.
- Attends professional seminars and engages in correspondence with others in similar positions.
- Provides technical expertise on integration technologies to simplify new or current systems and enhance the user experience.
- Reads standards, journals, and publications to keep abreast with requirements and developments in applicable technologies.
- Identity and promote new platform features and drive adoption.
- Understands the significance of deviations found within CSV programs and collaborates with local or Global Quality on completing deviations and assessing / remediating any issues discovered that have global impact.
- Communicates with clients on an ongoing basis to discuss systems compliance and/or functionality which meet their requirements.
- Reviews opinions and interpretations expressed by outside or internal IT personnel and determines best course of action
Qualifications and preferred experience:
- Bachelor's or advanced degree in information technology/business solutions.
- Minimum of 5 -10 years of pharmaceutical/biotech industry experience leading technology-driven platforms.
- Minimum of 10 years working in information technology where validation and compliance with FDA regulations were required.
- Previous experience working in ISO 17025 environment with strong knowledge of compliance requirements and how they align with FDA requirements in a GMP setting.
- LIMS and Project Management Experience
Perks of Working at Azzur:
- Medical, Dental and Vision
- Competitive 401K plan
- Flexible Paid Vacation Time
- Employee Recognition Program
- Diversity and Inclusion Initiatives
- Training and Mentorship Opportunities
Azzur is a GxP compliance and consulting organization dedicated to providing high quality, expertly backed, assistance that drives life science companies to success.
No matter where you are in the product development lifecycle, Azzur is here to help you start, scale, and sustain your business. From pre-clinical manufacturing to process design and process performance qualification, Azzur Group works hand-in-hand with our customers.
Do What You Love
We are seeking highly motivated individuals that have the desire to learn, are able to adapt to the ever-changing life sciences field and are flexible to work on various projects throughout the Southern California region all while exuding Azzur’s core values: Put Others First, Courage to Take Action, Take Personal Responsibility and Have Fun!
We aim to serve our clients, create a healthy and fun work environment, and assist with professional growth for each individual through customized career development plans. As a consultant working on multiple cross functional projects, you will be able to quickly garner a wide range of skills and areas of expertise that will propel your career progression.
If a clear career path forward and a positive, transparent, and fun company culture are something you are looking for in your next role, Azzur is the place for you!