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Form of workJob Description
Responsibilities:
- Write qualification and validation protocols/reports and other documentation related to the activities
- Responsible for performing process and equipment validation activities including, but not limited to, gathering historical data for product manufacture, analyzing data using statistical principles, writing validation protocols and reports, GDP review of data and reports, and final approval of validation protocols, reports, and deviations
- Author validation plans; assist with the development of specifications for user requirements, functional requirements, and design requirements, and cycle development protocols for manufacturing process steps.
- Support risk assessments and pFMEAs generations
- Leverage statistical tools/software such as MiniTab for the development of process validation strategies
- Validation of aseptic process & DS/DP manufacturing process (formulation & mixing studies, filling, buffer/media/process holding times)
- Experience with performing temperature and Humidity Mapping.
- Experience with Mapping Warehouses, Cold rooms, Freezers, Refrigerators, Stability Chambers etc.
- Experience Writing and executing Mapping Protocols.- Initial Qualification, Remapping.
- Experience writing summary reports.
- Experience with MadgeTech data loggers and software.
- Experience in performing Periodic reviews.
- Performing Periodic reviews especially on the following equipment:
- Packaging lines( Cappers, Fillers, Cartoners, Checkweighers, Sealers, Printers/Coders, Labelers, Serialization, etc..)
- Varies Mixers( Dissolvers, Counter Motion Mixers, Homogenizers, Versators, etc)
- Utilities( Compressed Air, USP Water, Alcohol), Neslab Chillers, Wonderware systems, Mills and Blenders.
- BS in Engineering, Science, or equivalent technical degree.
- 3-5+ years' experience in a regulated, manufacturing environment within the biotechnology, pharmaceutical or medical device industry.
- Experience in the areas of design documentation (URS, FS, DS and other engineering specifications) Validation (IQ, OQ, PQ, PV, CV, CSV, etc.), Quality Systems (Change Control, Non-Conformances, Requalification, etc.), and Process Excellence Methodologies (Six-Sigma, Lean, etc.).
- Excellent written and verbal communication skills; excellent technical writing skills.
- Strong interpersonal skills and the ability to work in a team environment.
- Ability to work effectively in a fast-paced multitasking environment.
- Strong working knowledge of FDA and cGMP regulations and documentation practices.
- Proficient in Microsoft Word, Excel, PowerPoint.
- Working for multiple clients throughout the region.
