Arcondis is a global consulting company with an exclusive focus on the healthcare and life science industries. Headquartered in Basel, Switzerland, the company has a global footprint with offices in North America, APAC and across Europe. We have been managing challenges and solving problems for our clients in compliance, business processes, information technology, and digital transformation since 2001. Our focus lies in creating value through cross-functional, sophisticated delivery methodologies and intelligent implementation. Our clients love to work with us because of our unique skillsets, our pragmatic approach, and our will to win.
We are a medium-sized international consulting firm dedicated to Life Sciences, with a unique and inspiring culture. Our distinctive culture is the driving force behind our success; it is deeply rooted in our purpose and behaviors.
We are owned by a charitable Foundation; our key differentiator is that we contribute to social causes every year. This ethos is not just a part of our identity; it's our way of life. Our motto, "We make healthcare better," reflects the unwavering commitment we have to improving the lives of people through the work we do.
Our culture fosters collaboration, innovation, and a sense of community that sets us apart from the rest. We are living our values every day. Our leadership is expected to lead by example, demonstrating a dedication to our mission and values.
We embrace diversity and inclusivity, and we believe in giving back to the community. Together, we are not just consultants; we are agents of change, and our culture is the driving force behind our shared purpose.
Business Services
Senior CSV SAP Validation Lead
1
- Minimum a bachelor’s degree in engineering or a scientific discipline
- Experience within the pharma/biotech or medicinal diagnostic industry is required
- Strong experience in SAP PP, solution manager, and preferably MM and WM is required
- 7+ years of experience supporting and/or performing all aspects of computer systems validation activities including the development of scalable validation strategies, documents, performing of document reviews
- 7+ years of experience in computer systems validation within GMP/GxP-regulated environments
- Proven experience developing full validation documentation and test protocols within the various SDLC phases that is scalable and maintainable to demonstrate continuous compliance
- Broad understanding of the ERP Tools, including experience and knowledge of Solution Manager AWS, and audit trail
- Experience with FDA 21 CFR Part 11
- Experience with the validation of SAP and/or MES system
- Preferably with experience in consulting CSV within the life science industry
- Strong project/program management skills
- Excellent written and oral communication skills
- Ideally located somewhere close to St. Petersburg, Florida
- Willing to travel
5a87998e-670d-47bd-869f-24ce8b7cd148
647066f9-b2e9-490d-8d35-ba5441c4fffa
fc7e4a51-60aa-4d79-a12e-7a9c7c127789
United States
Arcondis is a global consulting company with an exclusive focus on the healthcare and life science industries. Headquartered in Basel, Switzerland, the company has a global footprint with offices in North America, APAC and across Europe. We have been managing challenges and solving problems for our clients in compliance, business processes, information technology, and digital transformation since 2001. Our focus lies in creating value through cross-functional, sophisticated delivery methodologies and intelligent implementation. Our clients love to work with us because of our unique skillsets, our pragmatic approach, and our will to win.
We are a medium-sized international consulting firm dedicated to Life Sciences, with a unique and inspiring culture. Our distinctive culture is the driving force behind our success; it is deeply rooted in our purpose and behaviors.
We are owned by a charitable Foundation; our key differentiator is that we contribute to social causes every year. This ethos is not just a part of our identity; it's our way of life. Our motto, "We make healthcare better," reflects the unwavering commitment we have to improving the lives of people through the work we do.
Our culture fosters collaboration, innovation, and a sense of community that sets us apart from the rest. We are living our values every day. Our leadership is expected to lead by example, demonstrating a dedication to our mission and values.
We embrace diversity and inclusivity, and we believe in giving back to the community. Together, we are not just consultants; we are agents of change, and our culture is the driving force behind our shared purpose.
Business Services
1
- Minimum a bachelor’s degree in engineering or a scientific discipline
- Experience within the pharma/biotech or medicinal diagnostic industry is required
- Strong experience in SAP PP, solution manager, and preferably MM and WM is required
- 7+ years of experience supporting and/or performing all aspects of computer systems validation activities including the development of scalable validation strategies, documents, performing of document reviews
- 7+ years of experience in computer systems validation within GMP/GxP-regulated environments
- Proven experience developing full validation documentation and test protocols within the various SDLC phases that is scalable and maintainable to demonstrate continuous compliance
- Broad understanding of the ERP Tools, including experience and knowledge of Solution Manager AWS, and audit trail
- Experience with FDA 21 CFR Part 11
- Experience with the validation of SAP and/or MES system
- Preferably with experience in consulting CSV within the life science industry
- Strong project/program management skills
- Excellent written and oral communication skills
- Ideally located somewhere close to St. Petersburg, Florida
- Willing to travel
5a87998e-670d-47bd-869f-24ce8b7cd148
647066f9-b2e9-490d-8d35-ba5441c4fffa
fc7e4a51-60aa-4d79-a12e-7a9c7c127789
United States