Senior Validation Specialist

Transition Technologies MS; Polska; Hybrid; PLN 110,000 - 150,000; Full time

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.

Skills

CSV Validation

GAMP

Lean/Agile

Cross-functional teamwork

JIRA

ServiceNow

English (C1)

Education

Higher education in CS/SE/IS or pharma

Tools

Retina

JIRA

ServiceNow

Job description

Transition Technologies MS S.A. ("TTMS") is a global IT company and part of the Transition Technologies Group, one of the largest IT firms in Poland. Currently, TTMS employs nearly 800 specialists across eight offices nationwide.

TTMS is committed to growth and the continuous development of its employees' skills. We support large enterprises and global corporations by implementing and maintaining dedicated IT systems, as well as automating their business processes. TTMS is also a partner of AEM, Salesforce, Microsoft, and others.

Why join us? We carry out unique, complex, and innovative projects across various industries. Thanks to our flexible collaboration models and multidisciplinary teams, we provide end-to-end project solutions. TTMS is a modern company that cares about the future of our planet - we drive change through environmentally friendly IT solutions.

Our company leverages advanced AI-driven solutions to support the transformation of traditional processes into intelligent, automated operations. With AI solutions, we assist in business process optimization (integration of Webcon + AI), low-code application development (Power Apps), and reporting (Power BI, Snowflake Data Cloud).

Your responsibilities:

• Determine validation approach, identify deliverables needed or impacted by a project/enhancement / or change for GXP computerised systems
• Review of software documentation according to CSV corporate SOP's, and regulatory guidance
• Provide estimates and forecast validation activities for a project
• Author validation plans/reports, reviews test plans/reports (and other deliverables) to asses and notify that system is ready to go life
• Liaison with business quality/informatics quality to ensure compliance with corporate quality policies and standards
• Participate actively in validation discussions, and provide consultancy for all validation-related questions
• Review and collect expected CSV deliverables, records and other evidences according to plans
• Prioritize activities in line with the 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, are 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 permanent audit readiness
• Observe governance processes, escalates area for improvement
• Support system audit/inspection preparation and execution as CSV subject matter expert
• Implement relevant framework and processes, propose and uses tools
• Provide training and validation/quality knowledge/experience exchange support

We are looking for you, if you have:

• 3+ years experience 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), models, standards in pharmaceutical industry (or other regulated)
• Experience in maintenance and support of applications under global inspection agencies, CFR 21 FDA Part 11, Annex 11
• Aware of common development technologies and governance processes impacting validation approaches
• Ability to work collaboratively in cross-functional teams to achieve milestones and goals
• Ability to communicate clearly and professionally both in writing and verbally
• Ability to share knowledge and guide others
• Ability to make sound decisions about quality and technical subjects
• Follow-through and persistence : our team is globally spread and some key stakeholders, due to extremely busy schedules, will need chasing up for input/signatures
• Higher education degree or relevant work experience in computer science, software engineering, information systems and/or pharma industry
• Communication skills, English language mandatory (C1)
• Hands-on experience with Retina or JIRA (Backlog Management)
• Hands-on experience with ServiceNow (Incident, Change, Knowledge Management)

We offer:

• Participation in interesting and demanding projects
• A great, non-corporate atmosphere
• Stable employment conditions (contract of employment or B2B contract)
• Opportunities for development and promotion
• Attractive package of benefits
• Work model: remote or hybrid (2 days per week from the office)

We reserve the right to contact the selected candidates.