Senior Validation Expert

Our organization seeks a skilled validation professional to lead process and cleaning validation activities in a prominent pharmaceutical production site.

About the Role

This is a key quality position supporting both sterile and non-sterile product lines, offering strong long-term career potential.

Develop and execute comprehensive validation protocols in compliance with regulatory standards, working cross-functionally with Production, Quality Control, and Engineering teams.

Create detailed documentation, including validation reports and technical specifications.

Ensure all validation activities meet strict regulatory requirements and internal quality policies.

Collaborate closely with Production, QC, and Projects teams to implement a validation strategy.

Perform thorough risk assessments, contribute to Corrective Action Preventative Actions (CAPAs) and change controls.

Support site audits and inspections, ensuring compliance with regulatory standards.

Requirements

Bachelor's degree in a relevant field, such as Pharmacy or Life Sciences.

5+ years of experience in pharmaceutical validation, preferably with sterile products.

In-depth understanding of regulatory requirements.

Familiarity with systems like TrackWise, SAP, or similar quality management tools.

Proficient level of English (spoken and written).

Excellent attention to detail, technical writing skills, and ability to work collaboratively.

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