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.

We are currently seeking a Validation Lead to join our team. Remote work for the next few months due to COVID.

The Computer Systems Validation Lead will be responsible for oversight of all GxP-Regulated Computerized Systems at all applicable points of the computerized system lifecycle, ensuring compliance with regulatory requirements, company Computer Systems Validation (CSV) and Lifecycle procedures, and Data Integrity requirements. This individual will provide oversight of validation activities, lead the development and approval of validation documentation, risk assessments, work with project teams to determine which elements should be validated, and conduct impact assessments of proposed changes to computerized systems. The incumbent will provide the necessary oversight of system related issues, employ risk-based methodology, and ensure that all GxP computerized systems are maintained in a validated state throughout their lifecycle. Additionally, the individual will focus on ensuring consistent policy administration, implementing key improvement initiatives and solving compliance issues.

At NNIT, you can design your professional profile, and we will support you on that journey, through high focus on assignments, where you will be offered a number of certifications that will match your profile and continued development.

The Main Responsibilities For This Person Include

• Provide oversight of all GxP Computerized Systems, including IT and Automation systems, QC software, and IT infrastructure.
• Develop and approve system lifecycle documentation to ensure that procedures and methodologies are followed, and that appropriate and complete documentation is captured and reported to support CSV activities for assigned systems, including associated change requests.
• Maintain GxP computerized system inventory list.
• Represent IT Quality on all assigned projects in support of CSV activities.
• Consult on conformance of validation strategies and lifecycle deliverables to current regulatory requirements and company procedures.
• Provide timely and proactive support and guidance to IT and automation personnel in their System Development Lifecycle (SDLC) efforts to facilitate project timelines.
• Provide IT quality oversight of system-related issues.
• Employ risk-based methodology, where feasible and achievable.
• Escalate any potential compliance issues in a timely manner.
• Lead or support the development of procedures, work instructions, validation templates and training materials to ensure that the control of GxP computerized systems is integrated into Quality Management System.
• Support internal and client audits and regulatory inspections.
• Provide support in other quality system related activities including quality exceptions and change control.
  

The Main Skills Of The Person Include

• Education: BA/BS required in Life Sciences or IT related discipline with 5 years of appropriate work experience
• 3+ or more years working in a Quality role desired. Life Sciences biotech / pharmaceutical experience required.
• Knowledge of IT Control methodologies, including GAMP5 and solid understanding of GxP guidance, including 21 CFR Part 11, Annex 11 and Data Integrity.
• Knowledge of the computerized system lifecycle activities, CSV and IT controls in a regulated environment.
• Experience with system validation across GxP landscape, specifically GMP applications.
• Strong computer skills including Microsoft Word, Excel, and Access.
• Strong communication skills, both verbal and written.
• Ability to work both independently and with teams at various levels in the organization.
• Ability to work in a very dynamic environment with a clear sense of urgency.
• Excellent organizational skills and attention to detail and accuracy.
  

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