This position is responsible for Equipment and Sterilization Validation processes (i.e. included but not limited to Autoclave, SIP, tunnel, dry heat, and VHP studies), that supports commercial and new R&D drug development activities in support of the client projects involving all delivery systems manufactured in Lakewood, NJ plant.
This highly technical and highly specialized position is responsible for generating, reviewing and approving protocols, deviations and reports; as well as scheduling activities, providing internal and external customer feedback, and ensuring on-time delivery of milestone activities. The individual will be a Subject Matter Expert (SME) expected to oversee and execute the overall qualification activities related to the support activities or prerequisites to Process Performance Qualifications (PPQs, otherwise known as Process Validation).
This position will also interact frequently with regulatory/compliance personnel at Renaissance Lakewood LLC. It will ensure compliance to all FDA and international regulations with regard to equipment qualification and sterilization validation activities. The employee in this role must be able to represent Renaissance with customers and senior management.
Bachelors or master’s degree in Pharmaceutical Sciences, Engineering, Microbiology or similar degree and a minimum of three (3) years of relevant experience performing validation activities within an aseptic pharmaceutical environment is required.
Familiarity with current industry practices and guidelines including those required / outlined by the FDA, ISO, EU and ICH. Proficiency in Microsoft Office including Word, Excel, PowerPoint, MS Project, Visio, etc.
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