A Digital Solutions SME, is an experienced life sciences digital product expert that can consultant on and deploy data and verification tools to support digital transformation, Pharma and Validation 4.0. This role includes the full spectrum of client digital tools and data models. Digital tools include KNEAT or other similar paperless validation/digital validation products. The role is variable and can initially be focused on paperless validation with growth and support by CAI into other digital and Pharma 4.0 areas or it can support the direct hire of a Digital Solutions expert.
Can provide paperless validation consulting to internal and external clients to include:
1. Translate client paper-based processes to paperless processes
2. Develop process and discipline maps
3. Deploy templates within established process maps
4. Develop test case templates
5. Train clients on best practices and use of paperless validation systems
Additional roles include:
1. Assess client digital roadmap
2. Develop digital solutions architecture and plan
3. Conduct digital solutions risk assessment for quality & security compliance
4. Provide operational readiness consulting associated with site & project data mapping and system planning and implementation
You will have an opportunity to work with recognized subject matter experts allowing YOU to be a key player in bringing lifesaving therapies to market. As part of our company culture, we invest in YOUR future, and commit to hands on certifications as well as professional training. Our collaborative culture ensures that our customers benefit from exemplary work across our entire range of professional services.
BS or MS in a relevant science or engineering field, or equivalent
Excellent oral and written communication skills in English
Excellent skill in leading teams to perform complex tasks under pressure
Excellent problem-solving skills
Strong knowledge of CQV deliverables
Strong knowledge of QRM principles
Plus: Proficient in life science manufacturing processes in areas such as biotech, aseptic fill/finish, OSD, Gene Therapy or equivalent experience.
Plus: Two (2) or more years in roles for life sciences.
Excellent oral and written English is required
Able to travel domestically and internationally if required
Able to work (paid) overtime
Able to work in the US without sponsorship now or any time or in the future
Must have been vaccinated or willing to be vaccinated for COVID-19 prior to starting employment
CAI is a 100% employee-owned company established in 1996 that has grown to more than 700 people worldwide. We provide commissioning, qualification, validation, start-up, project management and other consulting services associated with operational readiness to FDA regulated and other mission-critical industries.
Meeting a Higher Standard
Our approach is simple; we put the client’s interests first, we do not stop until it is right, and we will do whatever it takes to get there.
As owners of CAI, we are committed to living our Foundational Principles, both professionally and personally:
We act with integrity.
We serve each other.
We serve society.
We work for our future.
With employee ownership, one person’s success is everyone’s success; we work diligently to accomplish team goals. We place Team Before Self, demonstrate Respect for Others, and possess a Can-Do Attitude (our core values). That is how we have grown exponentially.
Our full-time positions offer competitive compensation and benefits which include: up to 15% retirement contribution, 24 days PTO and 5 sick days per year, health insurance at extremely low cost to employee, financial support for both internal and external professional education as well as 70% long term disability paid for by the company.