Senior Equipment Validation Engineer

4 weeks ago

Trenton, United States Rbw Consulting Full time

RBW Consulting are excited to present an opportunity for a

Senior Validation Engineer

with a CDMO partner of ours

With over 20 years experience in the industry, they are passionate about supporting companies from Development to Commercial launch of their Sterile products, with a particular focus on Injectables.

Dedicated to quality and growth, our partner continually seeks to improve, over the past 5 years they have invested over $100M into their facilities to improve capabilities and expand capacity. Allowing you to work on large-scale projects and expand your own experience in a complex area.

Responsibilities

Technical Expertise : Provide in-depth technical knowledge related to equipment qualification, requalification, and sterilization processes. Validation Protocols and Reports : Develop and review validation protocols and reports for process equipment, critical utility systems, and environmental chambers during initial qualification and requalification. Document Preparation and Review : Assist in preparing and reviewing technical documents, including change controls, regulatory submissions, deviation investigations, validation protocols, summary reports, processing records, procedures, VMPs, and APRs. Aseptic Pharmaceutical Environment : Execute validation activities within an aseptic pharmaceutical environment. Regulatory Compliance : Ensure compliance with FDA, ISO, EMA, and other applicable domestic and international regulations. Technical Support : Provide technical support for start-up activities related to temperature mapping and sterilization programs. Requalification Activities : Support periodic requalification activities for production equipment and systems. Root Cause Investigations : Lead or assist in root cause investigations related to sterilization and other relevant activities. Data Analysis : Analyze manufacturing data using statistical principles to identify trends, process disruptions, and opportunities for continuous improvement. Cross-Functional Collaboration : Coordinate with cross-functional process teams to implement projects aimed at enhancing productivity, quality, and continuous improvement of sterilization processes. Audits and Inspections : Participate in equipment sterilization programs during internal and external audits, including regulatory inspections. Issue Resolution : Provide technical assistance for investigations into process/product issues, supporting validation deviations, and reviewing design requirements for products and equipment. Customer Interaction : Interface with customers during transfer discussions, project timelines, and deliverables. Safety Culture : Promote a safe working environment by adhering to safety rules and actively participating in safety-related activities.

Requirements 3+ years experience in Validation, including but not limited to Equipment and Sterilization Bachelors or master’s degree in Pharmaceutical Sciences, Engineering, Microbiology or similar degree Familiarity with current industry practices and guidelines including those required / outlined by the FDA, ISO, EU and ICH

If you could be interested in developing your career with a forward-thinking CDMO, please apply or reach out to me directly to organise a call.

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