This position is to support the process and cleaning validation programs and associated activities. To assist in formulation and manufacturing processes optimization. To collaborate on the Technology Transfer and Process Improvement programs for TAH. . To aid in the SOP development and revision process. Play a major role on the project teams in Process and Cleaning Validation studies. Write and execute validation protocol documents as directed. Assist in maintaining the tracking system for process and cleaning validation activities. Work on process optimization projects as directed. Support Technology Transfer and Process Improvement programs as directed. Draft SOPs required for validated products and systems as directed.
Responsibilities: Assist project teams responsible for Process Validation and Cleaning Validation, using good organizational and communication skills, to provide Production, R&D and Technical Services with properly validated production and cleaning processes. Write clear validation protocols (PV and CV) using knowledge of chemical and physical processes, technology transferred from Product Development areas (both internal and external to TAH) and input from other sources confirming that processes are properly validated. Execute validation protocols, using technical knowledge, to provide clear documentation of results and adequate resolution of all deviations. Assist in maintaining project tracking systems, using good organizational skills and computer knowledge, to provide this position's customers with current and reliable information regarding validation/ re-validation status. Support process optimization teams with broad knowledge of process and cleaning needs. Aid R&D in transferring technology gained from TAH Product development or external source. Write SOPs and MBRs that clearly represent the proper production activities and techniques to reproducibly produce products that meet intermediate and final product specifications for purity, performance and safety. Qualifications:
Minimum BS/BA in a scientific or engineering discipline, or equivalent work experience. 4+ years pharmaceutical engineering or equivalent experience. Good oral and written communication skills, attention to detail, ability to work independently, good interpersonal skills, demonstrated project management/organizational skills. Knowledge of pertinent technical information related to TAH equipment and products. Detailed knowledge of the chemical, physical and microbiologic processes that are required or which inhibit the production of TAH products. Familiarity with cGMP, SOPs, relevant government regulations, and current industry standards related to TAH product lines. Ability to communicate effectively with all levels of the organization. Capability in writing validation protocols and summary evaluation reports. Ability to identify and initiate project activities. Capability to track multiple projects. Ability to identify problems, develop hypotheses, test the hypotheses and analyze results. Knowledge of the use of problem analysis and solving tools such as process flow diagrams, FMEA, etc. .
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