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.

 

Requirements:

 

·          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.

Name
Email
Telephone
Message
Upload your CV/resume or any other relevant file. Max. file size: 256 MB.
Check the box to confirm our use of your data under GDPR regulations. To register your CV you must tick the checkbox to confirm your acceptance of our GDPR and Privacy Policy