Senior Validation Specialist
Your responsibilities:
- Development and implementation of validation strategies for MES systems at several international locations.
- Ensuring compliance with regulatory requirements, especially GxP, as well as internal quality guidelines
- Creation, review and approval of validation documentation such as risk analyses, test plans and reports
- Support in the implementation and qualification of new technologies taking compliance requirements into account.
- Collaboration with interdisciplinary teams to establish efficient and sustainable validation processes.
We are looking for you, if you have:
- Experience in validating IT systems, ideally in the area of manufacturing.
- In-depth knowledge of regulatory requirements (e.g. GxP, FDA, ISO 13485).
- Experience in creating and implementing validation documentation and processes.
- Strong analytical skills and solution-oriented thinking.
- Experience in an international environment and in working with global teams.
- Strong communication skills and ability to communicate complex regulatory requirements in an understandable manner.
- 3+ years experience in IT & Software Validation (CSV, GAMP), preferably in pharma environment
- 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)
- 3+ years experience in IT & Software Validation (CSV, GAMP), preferably in pharma environment
- 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 Lean and/or Agile approaches
- 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
- Higher education degree or relevant work experience in computer science, software engineering, information systems and/or pharma industry
- English language mandatory (C1)
- Determines validation approach, identifies deliverables needed or impacted by a project / enhancement / or change for GXP computerised systems
- Responsible for the 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
- Determine testing strategy, requirements and acceptance criteria
- Liaison with business quality/informatics quality to ensure compliance with corporate quality policies and standards
- Coordinate and advise on all validation activities on a global level/organizational level for system/project
- Participate actively in validation discussions, provide consultancy for all validation related questions
- Participate in system implementation and maintenance planning
- Lead and author system and functional risk assessments
- Verification of testing plans, activities, deliverables and records, provide consultancy on test related deviations and corrective actions
- 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 requirement Ensure code release to production and maintenance procedures are identified and adhered
- Assess changes to determine potential impact to the validated state of the computerised system Support system maintenance with validated state and permanent audit readiness
- Lead and author system periodic review according to procedure
- Observe governance processes, escalates area for improvement
- Support system audit/inspection preparation and execution as CSV subject matter expert
We offer:
- Interesting and challenging projects
- Flexible working hours
- Friendly, non-corporate atmosphere
- Stable working conditions (CoE or B2B)
- Possibility for self-development and promotion in the company
- Rich benefits package
We reserve the right to contact the selected candidates.
Why is it
worth joining TTMS?
Flexible working hours
Not everyone is comfortable operating a company during the standard 9 a.m. – 5 p.m. hours. We have been successfully running projects for many years despite diversified work patterns.
Possibility of remote work
At TTMS, desk-to-desk work is what drives us, but we understand if someone prefers a remote or hybrid model. We are equipped with all the necessary tools to perform either at home or in the office.
Great, non-corporate atmosphere
Professionalism, attention to the quality of work and a friendly, informal atmosphere are not mutually exclusive. A flat structure and natural, friendly relationships create the basis for creativity and innovation.
Interesting, international projects
We create solutions for medium and large companies, we are present in Poland, Malaysia, Denmark, the UK, Switzerland, and India – the effects of your work will travel around the world. In TTMS you have an influence on the company’s success.
Together towards climate neutrality
We select subcontractors to minimize the carbon footprint, organize bush plantings, save peat bogs – all to achieve climate neutrality in 2025. We are glad that we are attracting more and more people who also care about sustainable development and environmental protection.
Friendly offices
Our offices are modern spaces that inspire employees and are environmentally friendly. Białystok is the kingdom of Marvel superheroes, Krakow is a soothing tropical forest, Wrocław is an art gallery, and the Lublin branch is a rock “hall of fame”.
Would you like to work for us?
Sending CV
Include information about technical skills, knowledge of programming languages and IT tools, and possibly experience in projects.
Phone Screening
The interview is aimed at assessing the candidate’s suitability for the position and verifying basic information from the CV. It is also an opportunity to discuss the candidate’s expectations and briefly present the job description and working conditions.
HR + technical meeting
We talk about the candidate’s professional experience, but also expectations regarding the new job. This is also the moment to check references and confirm the authenticity of the information provided, which allows you to get to know the candidate better and assess his fit with the company’s organizational culture.
Client company meeting
The candidate is introduced to the client. This stage aims to match the future employee to a specific project, taking into account both their technical skills and design preferences, which maximizes the chances of successful cooperation.
Employment
We sign an agreement that includes the terms of cooperation, scope of duties, remuneration and other key aspects of employment, such as the rights and obligations of both parties. From now on, the candidate becomes an official employee of the company.
Onboarding + first day of work
A comprehensive process of familiarizing a new employee with the organization, team and tools, aimed at making it easier for him to join work as quickly and effectively as possible. In TTMS, we use an internal e-Learning platform to conduct modern onboarding.
Our offices
Warsaw
The heart of our company and our command center
The Management Board of the company and management of individual business areas function here. On a daily basis, it is here that the most important, strategic and business decisions are made, as well as pro-ecological iniciatives. The Warsaw branch – located in Varso Tower – aims to be the first to create a fully eco-friendly office using renewable Energy and environmentally friendly materials, which is confirmed by the BREEM certificate.