Validation Analyst/Specialist

Billennium is a global technology company with over 20 years of experience, committed to innovation and empowering businesses.

• 3+ years experience in IT & Software Validation (CSV, GAMP), preferably in pharma environment.
• Experience leading validation for projects and systems maintenance.
• Experience authoring validation plans, reports and deliverable registries.
• Experience authoring or reviewing validation related deliverables, records and other evidences.
• Experience in software development lifecycle processes (SDLC), models, standards in pharmaceutical or regulated industries.
• Experience in Lean and/or Agile approaches.
• Experience in maintenance and support of applications under global inspection agencies, including CFR 21 FDA Part 11 and Annex 11.
• Awareness of common development technologies and governance processes impacting validation.
• Ability to collaborate in cross-functional teams to achieve milestones.
• Clear and professional communication skills, written and verbal.
• Ability to share knowledge and guide others.
• Decision making on quality and technical subjects.
• Higher education or relevant experience in computer science, software engineering, information systems and/or pharma.
• English language skills mandatory (C1).
• Assertiveness, conflict management, and leadership skills.

• Creating and reviewing validation plans and reports in accordance with procedures.
• Monitoring key performance indicators and conducting comprehensive product validation.
• Identifying and analyzing data quality issues and providing solutions.
• Collaborating with quality assurance teams to meet regulatory requirements (e.g. GDPR, HIPAA, FDA 21 CFR Part 11).
• Coordinating validation activities globally and working with product teams.
• Preparing documentation for audits and inspections as a validation expert.

Technical interviews will be conducted in English. Role is under B2B contract type allowed by client.