Job Description Summary

Job Overview
Responsible for preparation of materials to support downstream manufacturing operations. May operate specialty preparation equipment. Weighs, measures and checks raw materials to ensure batches manufactured contain proper ingredients and accurate proportions following approved procedure. Assists with in-process testing to ensure batches meet specifications. Responsible for validating processes and equipment that are directly related to filtration, cleaning and sterilization. Assists in the removal and disposal of waste chemicals, solvents and acids. Identifies, troubleshoots, and resolves basic issues associated with bulking/formulation operations.

Job Description

Job Overview

            Responsible for preparation of materials to support downstream manufacturing operations. May operate specialty preparation equipment.  Weighs, measures and checks raw materials to ensure batches manufactured contain proper ingredients and accurate proportions following approved procedure. Assists with in-process testing to ensure batches meet specifications. Responsible for validating processes and equipment that are directly related to filtration, cleaning and sterilization. Assists in the removal and disposal of waste chemicals, solvents and acids. Identifies, troubleshoots, and resolves basic issues associated with bulking/formulation operations.

Responsibilities and Duties

• Weighs, measures and checks raw materials to ensure batches manufactured contain proper ingredients
• Performs simple analytical tests (pH, conductivity, and absorbance)
• Performs routine cleaning of processing equipment
• Handles hazardous waste as appropriate
• Assists with inventory counting activities as required
• Inspects in-process parts to ensure consistent quality and remove defective product, packaging, and component material
• Assists in the timely and accurate documentation of all manufacturing activities performed
• Monitors meters, gauges, temperatures, pressures, and related controls
• Assists in generating reports, graphs, and other data
• Assists in ensuring accurate proportions of batches following approved procedure
• Evaluates operating process equipment and implantation to ensure constant compliance with standard manufacturing practices (SMP)
• Uses independent judgment in troubleshooting and problem solving under general supervision
• Demonstrates the ability to follow established procedures according to Good Manufacturing Practices (GMP)
• Must follow all BD housekeeping policies and procedures
• Must follow all BD safety policies and procedures
• Must be able to work overtime as required to meet BD business requirements
• Perform other duties as required

Qualifications

Minimum Education/Experience:

• High School degree with 2 years’ manufacturing experience or AA science degree with 0 years’ experience.
• Minimum 1 year experience in an FDA/Regulated environment.

Basic Skills:

• Possess the ability to communicate (oral/written) technical and non-technical information across the group and organization
• Possess strong time management skills to complete assigned tasks in an accurate and timely manner
• Strong attention to detail

Proficient/Working Skills:

• Must be proficient in English with the ability to read, write, analyze/evaluate charts, follow simple diagrams and perform basic arithmetic
• Demonstrate the ability to use personal computers
• Proficiency in MS Excel is required
• Must be able to use advanced math skills to produce accurate formulas
• Possess the able to read, write, comprehend and interpret complex charts, drawings, diagrams, graphs and other data
• May require forklift certification

Primary Work Location

USA MD - Baltimore

Additional Locations

Work Shift

US BD 3rd Shift 10pm-630am (United States of America)