Validation Engineer – REF 01961MQ

Validation Engineer


Headcount Solutions is sourcing a Senior Validation Engineer for our clients biotech facility in Dublin. This person will provide Validation oversight of external manufacturing sites (API, DS/DP), including process, cleaning, filter and sterilization/sanitization validation activities.

The role will be working from home until Covid restrictions are lifted, site visits will be required 2021 (CMO sites are Germany, TBC).

Key Responsibilities:


·          Translate client requirements into the language of the CMO – can make a risk-based decision.

·          Validation document author/approver.

·          Ensure validated parameters are correctly incorporated in Master Batch Records.

·          Regulatory – aseptic processing system oversight (media fill, autoclave validation, EM) content authorship.

·          Validation change control assessment.

·          Perform Person in Plant activities as required.

·          Author applicable MA filing sections.

·          Write/review RTQs.

·          Determine validation strategy and outcome of validation activities.

·          Decision to approve or reject validation documentation.

·          Provide Validation position on related topics and strategy for the site.




·          Degree qualified in science and/or engineering.

·          Ideally 8 years+ biotech or pharmaceutical industry experience.

·          Significant Validation experience at Aseptic Manufacturing or API facilities. Validation experience – (manufacturing process validation, NPI all the way through to PPQ)

·          Familiarity with basic project management tools.

·          Ability to negotiate a strategic position after taking feedback from multiple sources (dealing with CMOs, communicate with others where English isn’t first language).

·          Strong project management, problem-solving, and analytical skills.

·          Ability to operate in a matrixed or team environment with site, functional, and executive leadership.

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