As a member of the Process Engineering team the individual will be engaged in supporting process development and optimization. This position will support both early stage and late stage development groups. The candidate who fills this position will be expected to contribute to the manufacturing and development of pulmonary drug formulations in R&D, GLP and GMP settings.
The principal objective of this position is to build, test, operate and maintain manufacturing equipment in the R&D and clinical facility as well as support development studies in the commercial facility. Some of the responsibilities of this position include:
- Execute particle process operations in R&D and early clinical cGMP facility and support development studies in the commercial GMP facility, including:
o Operate feedstock equipment, spray dryer, jet mills, capsule filling equipment and perform collector change outs
o Operate pressurized Metered Dose Inhaler (pMDI) filling equipment
o Dispense raw materials; sample powder for testing
o Performs routine physical characterization of products. (e.g. powder and feedstock characterization)
o Tabulates, documents, and assists in interpretation of process data
o Assists in troubleshooting of process-related issues
- Process equipment related responsibilities:
o Rinse-in-Place, manual and washer based cleaning of processing equipment (including spray drying, feedstock preparation, jet milling, MDI filling, capsule filling, glovebox) and processing areas
o Disassemble and Assemble R&D and GMP Clinical equipment
o Support maintenance of spare parts inventory and materials inventory
o Conduct equipment preventative maintenance activities
o Support equipment qualification activities
o Effectively communicate technical issues; perform equipment troubleshooting. Transcribe process data into spreadsheet templates
o Prepare summaries of data sets using Excel (e.g. calculate means, percentages)
o Provide feedback for areas of improvement; including process work flow
o Provide feedback on process part integrity and upkeep, and
o Document all activities per applicable protocols, SOPs and cGMPs in associated electronic lab notebooks or batch production records
- Maintain a safe working environment
o Observe and follow all safe operation practices
o Routinely inspect facility safety equipment
o Maintain a clean and clutter-free working environment
- Bachelor's degree in physical science, chemistry, chemical science, material science, engineering or related field preferred.
- 2+ years of experience working in a pharmaceutical production facility preferred
- Previous experience with assembly/maintenance of electronics and/or mechanical hardware
- Good oral and written communication skills with an ability to maintain documentation integrity to GMP standards
- Ability to work comfortably with Excel spreadsheets (e.g. - understands how to create/use formulas, links, and graphs).
- Ability to conduct a wide range of manufacturing efforts in GLP, GMP and R&D contexts. Experience in GMP is preferred.