Specific Responsibilities and skills and skills for position:
· Perform routine manufacturing data entry/gathering, analysis, and trending to determine statistical significance, and evaluate process variation and capability using statistical techniques and control charts.
· Support lead engineers in preparing presentations and documents for manufacturing reviews on a regular basis.
· Prepares required engineering and manufacturing documentation, for revision and approval by management.
· With guidance, performs routine tasks to aid technical investigations and assessment of deviations, particularly as related to data generation/gathering and analysis.
· Prepares required engineering and manufacturing documentation, for revision and approval by manager/supervisor.
· Supports the preparation of documents for Regulatory filings.
· Works on assigned projects through completion with limited direct supervision.
· Performs assigned activities on projects related to scale-up, validation, and technology transfer between sites.
· May assist with aspects for the specification, installation, utilization, qualification, and improvement of equipment used for solid dose and liquid products.
· May assist with equipment/process qualification (IQ/OQ/PQ) and validation (PV)
· May assist with drafting qualification/validation/technical protocols and reports.
Knowledge, Experience and Skills:
· BS degree in a science field, preferably in an engineering field or a related technical discipline.
· 1– 5 years of relevant industry experience with BS or BA
· Some knowledge/experience on statistical techniques including process capability, control charts, etc. is preferred.
· Basic knowledge/experience on manufacturing solid oral dosage and/or sterile injectables is a plus.
· Good verbal, written, and interpersonal communication skills are required.
· Normally receives limited instructions on routine work and general instructions on new assignments.
· Works on problems of a routine to basic scope where analysis of data requires evaluation of identifiable factors.
· Working knowledge of typical computer applications.
· Basic knowledge of Good Manufacturing Practices (GMPs).