Job Description

NNIT is one of the world’s leading consultancies for the past twenty years serving the Life Science industry around the world. We apply the latest advances in technology - such as IoT, AI, Virtual Reality, Augmented Reality, Data Analytics - to make Quality Assurance, Regulatory Affairs, Clinical, Pharma Production and Laboratory processes more effective and efficient for our clients. NNIT has grown by more than 1,000 people globally over the last four years, and we are rapidly expanding our US Operations.

NNIT Is seeking to add to their QA team for a West Coast Client. Working in NNIT means being part of an international team with talented colleagues who all work the NNIT way; doing their best to make a mark on business and society; bringing digital transformation to life.

What you will be doing in the role:

Review and approve: Validation Plans; Specifications; Trace Matrices; Test Plans; Test Cases; Executed Test Results; Validation Summary Reports; deviations; change Provide lean and efficient compliance approaches for GxP lab systems- while still ensuring minimal in-service deviations / operational problems post-system deployment.

This is an opportunity to directly impact how validation / compliance is implemented and work with state-of-the-art systems.

The main skills of the person include:

Education: Undergraduate degree in science or engineering. Advanced technical degree an advantage.

Required relevant experience:

Senior Role

• 8+ years of validation experience- leading validation projects with hands-on involvement in developing and implementing the compliance strategy.
• At least 1 year of QA experience on lab systems >1 year lab systems QA experience
  
  

More junior role:

• 5+ years of lab systems validation and involvement in driving validation strategy.
• Some QA experience / ability to demonstrate “QA mindset”.
  
  

Technical skills:

• Hands-on experience operating major lab systems e.g. LES, LIMS.
  
  

All Levels:

• Excellent written and spoken communication.
• Experience with scheduling of lab operations.
• Advanced understanding of Laboratory Execution Systems (LES).
  
  

Soft skills:

• Ability to understand/make technical arguments (from science and IT perspective) to help stakeholders arrive at best decisions.
• Judgment & “backbone” to know when to give on a point and when to stand-firm.
  
  

NNIT has a unique culture and approach to business that is quickly making us an employer of choice in the US. We are open, honest and value-adding in everything we do. Whether it’s our weekly Friday meetings for all of our US employees, or our annual company-wide Kick-Off meetings, NNIT encourages employees to lean in and participate in creating new ideas and developing best practices. We want to grow our people through training and certification opportunities, as well as providing them with “stretch assignment” opportunities to gain experience in new areas. We encourage employees to work at our client sites to maximize NNIT’s value and are also open to working remotely when possible. We strive to have a good work-life balance for all of our employees.

Apply today and find out the types of career opportunities NNIT can offer you!

NNIT is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. If you require accommodations to apply for this or any of our roles due to a disability. please contact jqhk@nnit.com