CSV Specialist (Fixed Term)

About the Company

Through the work that we do, the team at Deciphex helps pharma to accelerate the process of essential drug development and helps patients to get timely and accurate diagnosis. 

Founded in Dublin in 2017, Deciphex has scaled rapidly to a team of over 190 people and counting who are providing software solutions to address the pathology gap in research pathology and clinical areas. We have offices in Dublin, Exeter, Oxford, Toronto and Chicago and are expanding our team throughout the world. 

We are software developers, clinical specialists, AI engineers, operations professionals and so much more, all working as one team to support our customers and patients.  Our team culture is built on trust. We give our team the space they need to deliver results and the environment to ensure they can enjoy doing it.

We are looking for highly motivated  individuals who are excited to take on challenges and value making a difference in their day-to-day work. This is a unique opportunity to make a difference in the emerging Digital Pathology field.  

Read more about Deciphex here and more about our incredible team on our Careers Page here 

About this Role (Responsibilities): 

• Collaborate with clients on projects to validate the Patholytix Preclinical SaaS for regulated intended use
• Develop and maintain Validation and Test Plans, aligned with the overall project plan for a customer environment
• Provide input to the development of realistic project schedules and document trackers
• Manage customer facing deliverables of our Software Development LifeCycle (SDLC)
• Ensure Change Control Summary Reports are delivered to clients in a timely manner post-software release
• Work as part of a cross-functional team to identify and implement procedural controls to mitigate issues found during testing
• Identification and resolution of any issues (process or software) that may cause Regulatory scrutiny for our validated clients
• Provide guidance, review and oversight for all CSV documentation within Deciphex
• Work closely with validated clients to navigate their Change Control processes when upgrading between versions of the Patholytix Preclinical platform

About You (Skills and Experience):

• Bachelor’s degree (or higher) in a relevant discipline
• Minimum of 5 years’ experience in a similar role delivering validated IT solutions, ideally in the Biotech or Pharmaceutical industry or other regulated environments
• Minimum of 2 years of experience working in a GxP environment
• Expert knowledge of GAMP5
• Experience in the following is essential:
  • GxP computer validation
  • CFR 21 Part 11, CFR 21 Part 58
  • IQ, OQ, PQ, UAT / SAT
  • Strong Project Management skills
• Experience in or working under a regulated environment or any of the following considered a distinct advantage:
  • CFR 21 Part 820
  • ISO 13485
  • Experience with AGILE and SCRUM
• You will have shown leadership skills in previous positions and are keen to develop these skills further. 
• You bring a sense of urgency to the work that you do and are able to execute on tasks by using your initiative.
• You enjoy innovating and bringing new ideas to the table.
• You like to have autonomy in your role and the independence to manage your own time and workload. 
• You are highly collaborative and  enjoy working with lots of different teams and people. 
• You have great written and oral English language skills. 

What are the benefits of working with Deciphex? 

• Competitive salary with performance based annual increments.
• Healthcare benefits
• Competitive annual leave 
• A true sense of meaning in your work by contributing to better patient outcomes. 
• The opportunity to work alongside a world-class high performing team in a hyper-growth startup environment. 
• A chance to work on exciting,challenging and  unique projects. 
• Regular performance feedback and significant career growth opportunities.
• A highly collaborative and supportive multi cultural team. 

Deciphex is an equal opportunities employer and we are committed to the principle of equality. All qualified applicants will be considered for employment without regard to age, race,  religious beliefs, political views, gender identity, affectional or sexual orientation, national origin, family or marital status (including pregnancy), disability, membership of the travelling community or any other classification protected by applicable law.