Global Validation Specialist | CSV & Change Management

Boehringer Ingelheim; Wrocław; On-site; PLN 90,000 - 130,000; Full time

Job summary

Boehringer Ingelheim is seeking a Validation Specialist in Wroclaw to oversee computer system validation activities within GBS Enabling Services, applying agile Principles to improve processes. You will coordinate change requests, perform impact analyses, review and approve documents, and ensure systems stay in a validated state, while collaborating with local experts and cloud suppliers.

The role requires 2–4 years in Validation Management, a bachelor’s degree, and fluent English; a fixed-term

Qualifications

• 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).
• Bachelor’s Degree; preferably in engineering, sciences, pharmaceuticals, or biotechnology or equivalent.
• Good Knowledge of GxP 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.

Responsibilities

• 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 KPIs and SLAs, while identifying opportunities for continuous improvement.
• Demonstrate exceptional organizational skills, with the ability to multitask and manage workload in a dynamic environment.

Skills

Validation expertise

Agile methods

Documentation & testing

Analytical thinking

Communication skills

Education

Bachelor's degree in engineering, sciences, pharmaceuticals, or biotechnology

Tools

JIRA

Job description

Boehringer Ingelheim is seeking a Validation Specialist in Wroclaw to oversee computer system validation activities within GBS Enabling Services, applying agile Principles to improve processes. You will coordinate change requests, perform impact analyses, review and approve documents, and ensure systems stay in a validated state, while collaborating with local experts and cloud suppliers.

The role requires 2–4 years in Validation Management, a bachelor’s degree, and fluent English; a fixed-term