Hobson Prior are seeking a Validation Manager to join a global life sciences company who are recognised for protecting and enhancing life and driving innovation. As working part of the MSAT team you will be accountable for developing a core competency in process-, cleaning- and shipping validation for biotechnological products at late phase clinical trial material production.

Please note that to be considered for this role you must have the right to work in this location.

Job Responsibilities:

• To perform all functions associated with process-, cleaning- and shipping validation (strategy, planning, writing of plans/ protocols, execution support, reports).
• Provide data, analyses, write-ups, reviews, and other input to annual Product Quality Reviews.
• Author and lead process risk analysis, critical process parameter and critical quality attributes identification and define control strategy.
• Complete process monitoring (control charts) and statistical process analysis including authoring of continuous process verification reports.
• Make recommendations for process changes and sponsor these to the larger process team.
• Represent Process Validation on global project teams and validation councils.
• Interface with customers technical and Quality representatives.
• Represent Process Validation on internal teams (e.g. Deviation and project meetings).
• Partake in internal, customer and regulatory inspections.
• Author and support of deviations and change controls in manufacturing.
• Recognise potential root causes of process variation and deviations using a systematic approach. Expertise in use for a variety of problem-solving tools e.g. Ishikawa, five-whys, etc. Resolve complex problems and lead multidisciplinary teams in developing and implementing solutions.
• Actively drive OE and EHS improvements.

Requirements:

• Bachelor's degree or higher in Life Sciences.
• A minimum of 10+ years' experience in GMP regulated Life Science industry (preferably Biotech).
• You are highly autonomous and initiative.
• Excellent written (especially technical writing) and verbal communication skills in English - German (Desirable).
• Experience with mid and large-scale process- and cleaning validation.
• Disposable technology experience is a plus.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.