PMN Technical Services Engineer II - United States
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- Completes technical assessments and investigations for commercial products.
- Manages tech transfer, scale up, and optimization of newly developed products from R&D to the Operations groups.
- Revise existing Manufacturing Orders, Ingredient Disclosures, Excipient Threshold Limits, to support process optimizations.
- Run commercial scale formulation and scale-up work, perform developmental trial batches to support post launch submissions.
- Manage projects to support MRB, PEM, and PPT.
- Lead and drive execution of manufacturing projects to support life-cycle changes including infancy/monitoring programs for new product launches and implementation of corrective and preventative action in response to process failure investigations.
- Ability to work independently on multiple concurrent projects with minimal guidance and to meet project deadlines.
- Must possess in depth knowledge of principles, concepts and practices in pharmaceutical sciences and manufacturing processes.
- Interpersonal, organization and communication skills, ability to work effectively with staff members at all levels, strong technical writing skills, familiarity with cGMP and FDA regulations.
- Understanding of development and/or reformulation of tablet and liquid formulas required.Computer literacy with a working knowledge Microsoft Office (Excel and Word), with SAP experience.
- Demonstrated ability to work independently on multiple concurrent projects with minimal guidance and to meet project deadlines.
- Bachelor’s degree in Engineering, Chemistry, Pharmaceutical sciences or related field, with two to five years of practical pharmaceutical process support engineering experience.
- Bachelor's degree required: consideration may be given to those who hold 8+ years of progressively responsible and relevant work experience.
- Masters degree in Engineering, Chemistry, Pharmaceutical sciences and Yellow-belt Lean Sigma Status preferred but not required.