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Sr. Development Engineer
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Pharmaceutical industry today.
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Sr. Development Engineer : GlaxoSmithKline
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| Job Number |
61189 |
| Employee Type |
Full Time |
| Company Name |
GlaxoSmithKline |
| Location |
Parsippany
New-Jersey
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| Salary (year) |
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| Experience |
2 to 5 Years |
| Start Date |
7/16/2010 |
| Industry |
Pharmaceutical |
| Job Type |
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| Relocation |
Not Required |
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| Description |
Basic Qualification
BSc. in Chemical or Process Engineering or related discipline with at least 10 years of industrial experience in pharmaceutical, healthcare or food sectors.
Excellent communication skills with the ability to interact at all levels from floor shop to management.
Excellent teamwork skills - able to fit in and work in a team environment
Good practical skill - capable of planning and executing experimental campaigns designed to achieve desired goals. Comfortable operating processing equipment and an ability to quickly learn new equipment.
Good personal organization skills - able to break down a task into its component parts and prioritize accordingly. Able to plan own workload and deliver in line with assigned targets.
Good technical report writing skills - able to convey complex technical information in a way that can be assimilated by other scientists.
Good mathematical ability - statistics and design of experiments would be an advantage.
Computer literate - able to operate email, word processing, spreadsheet and presentation software.
Demonstrated understanding of QbD, PUCC and associated tools.
OE Green Belt
Proven Project Management skills
Demonstrated ability to train and mentor junior members of the team.
Solid dosage experience.
Details
Provides process development and scale up expertise as the engineering lead in the weight control, new product development team (NPD). Main project areas include solid dosage, semi solid and liquid products of OTC medicines and nutritional products.
Contributes to the processing related knowledge of NPD in the areas of process innovation, development, scale up, tech transfer, process validation for assigned projects.
Conduct process development experiments at laboratory and pilot plant (1/10th scale) including DoE. Organize and prepare the raw materials/componets required and draft GMP documentation.
Development of scale up understanding and product/process characterization. This may include:
- Manufacturing of development batches
- Leading the cleaning validation/verification for equipment as needed
- Write, review and approve GMP critical documentation such as validation protocols, batch records, development and tech transfer reports.
- Scale up/down from pilot to commercial scale
- Developing and understanding or developing scale up rules that can be used by other engineers.
- Developing and implementing experimental plans (including use of DoE), recording and reporting of results.
- Gathering data generated at various scales to help develop and validate scale up models.
- Developing an understanding of how quality attributes are correlated to process parameters.
- Developing a design space/control space for processes.
- Writing and publishing (as appropriate) of scale up understanding findings and helping to embed understanding in NPD.
Publish work externally to develop and maintain standing in scientific community. |
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| Requirements |
Preferred Qualification
PhD or MS degree
OE Black Belt |
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| Contact Info |
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