Cleaning Support Engineer I - United States
Major Duties / Responsibilities | % of Time
- Completes technical assessments for commercial products. | 35%
- Manages tech transfer of newly developed products from R&D to the Operations groups. | 5%
- Revise existing Manufacturing Orders, Ingredient Disclosures, Excipient Threshold Limits, wash procedures/checklists to support continuous improvement.. | 20%
- Run lab scale formulation and scale-up work, perform developmental wash trials. | 10%
- Manage projects to support MRB, PEM, PPT and CV processes. | 30%
- 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 preferred.
- Computer literacy with a working knowledge Microsoft Office (Excel and Word), with SAP experience preferred.
- Bachelor’s degree in Engineering, Chemistry, Pharmaceutical sciences or related field.