Senior Computer Software Assurance Engineer

CSA · Oradea, Bihor
Department CSA
Employment Type Full-Time
Minimum Experience Experienced

WHO WE ARE

BTR’s mission is to help Healthcare improve the lives of patients by making it easier for the industry to adopt cutting-edge technologies. Over the next 10 years, the research being done today will turn into therapies that will revolutionize how we treat cancer and other illnesses. We are doing our part to help these innovations get to patients quicker, and safer.
Combining automation with deep regulatory expertise, our software ensures the technologies used to bring new products to market meet the requirements of the FDA and global health authorities.
BTR was founded by a team of who have been at the forefront of Life Sciences software for almost 20 years. We have helped over 250 companies transform how they research, manufacture, and monitor the safety of their therapies.


We’re looking for Senior CSV Engineer with a natural talent for learning new software, who are eager to work directly with our Services and Product teams to add real value to our Life Sciences customers.

 

WHO YOU ARE

  • Minimum of 3 years of Cloud CSV experience within the Life Sciences industry and GxP regulated environments
  • Excellent command and highly proficient in spoken and written English
  • Able to articulate concepts and requirements from SDLC, CSV, 21 CFR Part 11, EU Annex 11, and GAMP-V
  • Proven experience leading and managing customer interactions during projects
  • Able to lead project teams to work through technical problems

RESPONSIBILITIES

  • Work directly with health care companies adopting cutting-edge technologies to improve the lives of patients
  • Lead CSV projects in parallel, across different customer systems, ensuring all projects are delivered with customer success
  • Partner with Services and Product to define requirements and ensure systems work as intended Participate and lead process, product, and/or best practices initiatives
  • Be a thought leader

NICE TO HAVES

  • Direct experience with Veeva Vault
  • Experience with Health Authority Inspections and internal/external audits
  • Life Sciences, computer science, technology or related degree

OUR VALUES

Do the Right Thing. A shared purpose and values, guided by integrity, with the interest of all stakeholders in focus. Our #1 value in every single decision.

Clear and Transparent. Direct, concise, and open communication builds trust and improves accountability.

Always Add Value. We are dedicated to being a company where everyone has the motivation and support to improve.

 

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. 


Benefits

100% remote working
Competitive Compensation + Equity

Private Healthcare Coverage

Generous equipment budget

Knowledge and Skills Grant

Thank You

Your application was submitted successfully.

  • Location
    Oradea, Bihor
  • Department
    CSA
  • Employment Type
    Full-Time
  • Minimum Experience
    Experienced