Validation Specialist (Master Data Management, fixed-term contract)

our future Intern; Wrocław; On-site; PLN 120,000 - 180,000; Full time

Job summary

Boehringer Ingelheim Pharmaceuticals, Inc. in Wrocław is seeking a Validation Specialist to map and optimize the GBS Enabling Services' validation processes.

You will coordinate change requests, perform impact analyses, review documents, and ensure systems stay in a validated state within an agile, cross-functional team. The role requires 2–4 years in Validation Management (CSV) or a tightly regulated quality role, a Bachelor’s degree, and fluent English.

Qualifications

• 2–4 years of experience in Validation Management, ideally in CSV, or in a quality role in a regulated environment.
• Bachelor's Degree; engineering, sciences, pharmaceuticals or biotechnology preferred.
• Knowledge of GxP regulations is advantageous.
• Experience with Master Data or Reference Data is an asset.
• Experience with Test and Change Management is a plus.
• Experience with Agile methods (SCRUM, Kanban) and JIRA is beneficial.

Responsibilities

• Coordinate activities around change requests and impact analyses.
• Review and approve validation documents and ensure a validated state of systems.
• Support daily operation of processes and applications.
• Ensure processes and systems are compliant and validated.
• Manage testing activities and documentation.
• Apply Agile methods and participate in projects driven by this methodology.

Skills

Analytical thinking

Problem solving

Communication

Team player

Organizational skills

Education

Bachelor's Degree in engineering/sciences/pharma/biotech

Tools

JIRA

Job description

The position

Joining our company, you will gather an overview of the GBS Enabling Services Organization with a particular focus on the tasks and responsibilities from Validation Management. You will work in a globally operating team that designs, builds and continuously improves Boehringer Ingelheim's global Processes, using agile principles, methods and tools on a daily basis. You will be qualified to contribute to a cross-functional team, and as a Validation Specialist you will be able to coordinate the activities around change requests, performing impact analysis, reviewing, and approving documents and ensuring a validated state of the system.

Employment details: Fixed-term contract for 12 months, consisting of an initial 3-month contract followed by a 9-month extension.

Tasks & responsibilities

As a Validation Specialist, you will:

• Use your expertise in Computer System Validation to ensure that changes are managed according to our validation rules in close cooperation with local experts in our GBS user community as well as cloud application suppliers.
• Support our daily operation of processes and applications.
• Ensure that our processes and systems are always compliant and in a validated state.
• Manage the execution and documentation of testing activities.
• Apply Agile methods and tools, actively participating in projects driven by this methodology.
• Work on projects and contribute to achieving Key Performance Indicators (KPIs) and Service Level Agreements (SLAs), while identifying opportunities for continuous improvement.
• Demonstrate exceptional organizational skills, with the ability to efficiently multitask and manage one's own workload effectively and ensuring timely completion of tasks and adherence to deadlines in a dynamic environment.

About our future employee

You should speak English fluently and have 2-4 years of experience in Validation Management, ideally in Computer System Validation (CSV), or in a Quality role within a highly regulated environment (pharmaceutical, medical devices or FMCG industry).

Additionally, we are looking for:

• Bachelor's Degree; preferably in engineering, sciences, pharmaceuticals, or biotechnology or equivalent.
• Good Knowledge of GxP (Good Practices) regulations would be an asset.
• Experience with Master Data or Reference Data would be an asset.
• Experience in Test and Change Management would be an advantage.
• Experience with Agile methods (e.g. SCRUM, Kanban) and tools (e.g. JIRA) would be an advantage.
• Agile, accountable, and entrepreneurial mindset with a dedicated solution and result orientation.
• Good analytical capabilities and problem-solving competence including a proper understanding of prioritization.
• Dedicated team player with good communication skills, and a structured way of working.

At Boehringer Ingelheim, we are committed to fostering an inclusive workplace that values diversity in all its forms, including disability. Our accessible office environment and dedication to equal opportunities support every employee in reaching their full potential.