Senior CSV Validation Specialist (Remote/Hybrid)

Transition Technologies MS

Polska

Hybrid

PLN 110,000 - 150,000

Full time

5 days ago

Be an early applicant

Application generator

Turn this role into an interview — a resume and cover letter built around what this employer wants.

Get past ATS filters

Benefits offered by this job

Remote or hybrid work

Hybrid work 2 days per week in-office

Job summary

Transition Technologies MS S.A. (TTMS) invites skilled professionals to join our global IT team pursuing advanced validation projects for pharmaceutical systems. You will lead CSV validation activities, write plans and reports, and ensure alignment with GAMP and CFR 21 Part 11 requirements.

We offer stable employment (B2B or contract), remote or hybrid work, and opportunities for professional growth. Join a team that values quality, collaboration, and continuous improvement across international

Qualifications

3+ years in IT & Software Validation (CSV, GAMP), preferably in pharma environment.
Mandatory Experience in Lean and/or Agile approaches.
Experience in leading validation for projects and systems maintenance.
Experience in authoring validation plans, reports and deliverable registries.
Experience in authoring or reviewing validation related deliverables, records and other evidences.
Experience in software development lifecycle processes (SDLC) in pharmaceutical industry (or other regulated).
Experience in maintenance and support of applications under global inspection agencies, CFR 21 FDA Part 11, Annex 11.
Awareness of development technologies and governance processes affecting validation approaches.
Ability to work collaboratively in cross-functional teams and communicate clearly.
Higher education or relevant work experience in computer science, software engineering, information systems and/or pharma industry.
English language mandatory (C1).
Hands-on experience with Retina or JIRA (Backlog Management).
Hands-on experience with ServiceNow (Incident, Change, Knowledge Management).

Responsibilities

Determine validation approach, identify deliverables needed or impacted by a project/enhancement or change for GXP computerised systems.
Review software documentation according to CSV corporate SOPs and regulatory guidance.
Provide estimates and forecast validation activities for a project.
Author validation plans/reports, reviews test plans/reports to assess and notify that system is ready to go live.
Liaison with business quality/informatics quality to ensure compliance with corporate quality policies and standards.
Participate actively in validation discussions and provide consultancy for validation questions.
Review and collect expected CSV deliverables, records and evidences according to plans.
Prioritize activities in line with project schedules, business needs and compliance requirements.
Ensure code release to production and maintenance procedures are identified and adhered to.
Confirm initial data loading and/or data migration from other systems, performed according to approved procedures.
Assess changes to determine potential impact to the validated state of the computerised system.
Support system maintenance with validated state and audit readiness.
Observe governance processes and escalate areas for improvement.
Support system audit/inspection preparation and execution as CSV subject matter expert.
Implement relevant framework and processes, propose tools and methods.
Provide training and validation/quality knowledge exchange support.