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).
· 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.