Senior Validation Specialist

​Professional  |  Permanent  |  Full-time  |  On-Site​

Our people in Manufacturing & Global Operations share two priorities: getting things done and making things better. If you’re a dynamic person with a positive mindset, you’ll fit in well here. It’s an international team with a powerful spirit of collaboration. Together, we make sure our products meet the highest standards of quality by constantly searching for ways to improve at every stage of our value chain – from the raw materials we buy through to the logistics network that brings our medicines to patients. Join our team and help us make an even bigger contribution to Grünenthal’s future.

What the job looks like

Each day you'll enjoy a variety of challenges, such as:

• Provides senior-level technical oversight for process and cleaning validation activities throughout the product lifecycle.
• Reviews and develops validation strategies—both process and cleaning—aligned with manufacturing needs and lifecycle expectations.
• Performs impact assessments, supports technology transfers, and defines validation requirements for new or modified processes.
• Identifies and monitors CQAs, CPPs, CMAs, and CCPs; conducts CPV/OPV trending to ensure sustained process performance.
• Ensures compliance with FDA, EMA, and PIC/S expectations regarding validation, equipment qualification, and lifecycle risk-based approaches.
• Maintains the State of Validation (SoV) through periodic reviews, timely requalification, and continuous monitoring of process robustness.
• Evaluates the impact of raw material source changes, formulation changes, or manufacturing variability on validated processes.

What you'll bring to the table

To make the most of this role and truly thrive, you should have:

• Degree in Science, preferably in Pharmaceutics, Biotechnology, Chemical Engineering, or a related scientific discipline.
• At least 5 years of experience in process validation, cleaning validation, manufacturing, formulation, or QA/QMS.
• Intermediate English proficiency (advanced desirable) across grammar, writing, reading, and conversation.
• Strong background in lifecycle and risk-based validation aligned with global regulatory standards.
• Ability to design, execute, and defend validation strategies that ensure process consistency and compliance.
• Proficiency with statistical tools such as Minitab or JMP to analyze process performance, variability, and trending data.
• Familiarity with MS Project or similar tools to manage validation timelines and deliverables.
• Strong problem-solving skills and the ability to anticipate and mitigate risks that could compromise the validated state.

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Juan Sebastián Valencia Florez, the Hiring Manager