Consultant / Senior Consultant / Project Manager

Provide consulting services in Digital Transformation in the Life Science Manufacturing domain in one or more of the following disciplines:

• Computerized System Validation CSVIT Infrastructure Network Qualifications
• Laboratory Instruments/Equipment
• Production/Manufacturing System
• Manage SDLC (system design life cycle) including risk, deviation, change managements e.g., conduct risk impact or functional assessment(s)
• Ensure Good Documentation Practices, working with policy and procedural governances, assessments, plans, reports, etc.
• Manage, develop and execute FAT/SAT, qualification protocols and test scripts with relevant quality and/or industry best practices
• Review, analyze, evaluate system functions and processes to deliver validation deliverables

Professional Skills and Experience:

• Minimum 2 years with at least BSc in technical discipline e.g., Engineering, Science, IT or with relevant experience to the job description
• Experience in engineering automation such as DCS, OSI PI Historian, Mfg systems and services, would be viewed favorably
• Ability to communicate quality and risk-related concepts to technical and non-technical audiences
• Good written and oral communication skills, presentation, and data analytics with center of excellence
• Demonstrated ability to work as both a team player and independently
• Good organizational skills and ability to follow assignments through to completion and meet timelines with commitment to task and attention to detail
• Develop approach using science, or risk-based approach that meets with good interpretation to regulatory regulations

Candidates with any of the following experience will have a distinct advantage:

• Foundational understanding of ICH Q7/Q9, 21CFR Part 11, EU Annex 11, and regulatory standards
• Familiar with IT Standards e.g., ISO 27000, ITIL, COBIT, etc.
• Provide support to Mfg Automation, Mfg-IT and/or implementation, patch/hotfix and/or SDLC management such as change/issue/incident/release, etc.
• Knowledge of ISO 9001, GAMP 5, ISA 88, ISA 95, and other relevant pharmaceutical standards
• Consultation roles for international healthcare clients in strategically relevant projects
• Work in a professional consultancy environment within a highly motivated team
• Opportunity to take on responsibility and to help shape our organization
• Excellent career development and growth opportunities in a premier consulting organization
• Structured training program and peer mentoring system towards competence and personal growth

About NNIT

NNIT is a public listed company that specializes in IT solutions to life sciences internationally and to the public and enterprise sectors in Denmark. We focus on high complexity industries and thrive in environments where regulatory demands and complexity are high. We advise on and build sustainable digital solutions that work for the patients, citizens, employees, end users, or customers. NNIT consists of group company NNIT A/S and subsidiaries SCALES, Excellis Health Solutions, and SL Controls. Together, these companies employ more than 1,800 people in Europe, Asia, and the USA.

We celebrate diversity and are committed to creating an inclusive environment for all employees. All candidates are encouraged to apply for the given job regardless of their gender, age, religious beliefs, sexual orientation, national and social origin, political opinion, disability, race, skin color, and ethnic origin.

In the interest of fostering a fair and unbiased recruitment process, we kindly request candidates to refrain from including their pictures in their applications.