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.

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.