Process Engineer - Pharmaceuticals
Company: Cameron Craig Group
Posted on: January 13, 2022
This Process Engineer position is responsible for working on all
aspects of the technology transfer for sterile drug products,
specifically Blow-Fill-Seal (BFS) and Inhalation products. This
would include working with Formulation and Analytical Development,
Quality, Production and Regulatory to identify product and process
criticalities and how to maintain them along with finding creative
solutions to any roadblocks in the Transfer process.
This role is also responsible to maintain necessary timelines for
the transfer and any associated ancillary activities.
The individual in this role is responsible for working on multiple
projects simultaneously with minor supervision in a fast-paced
environment. Aside from Technology Transfer activities, the
position requires writing and reviewing of technical documents to
support, including protocols, reports, methods, specifications,
SOPs and technical assessments. The Process Engineer is expected to
work with Development to support process development within a
This position will be responsible for participating in and leading
interdisciplinary teams throughout the product lifecycle.
- Perform scale up/development work associated with site
transfers of drug products.
- Work with Cross Functional Teams (CFTs) to identify
criticalities to transfer and identify development requirements to
- Work on process development activities of multiple projects
- Write and review technical documents including formulation
development protocols and reports, SOPs, specifications, and other
necessary technical documents.
- Work with R&D and Validation on process development to
support from scale up to commercial validation.
- Participate in multidisciplinary project teams through the
complete product transfer to support the filing cycle.
- Organize, and lead technical discussions to support process
development and filing timelines.
- Provide guidance and training to production employees on
general and product specific criticalities.
- Work with Cross-Functional team leads in order to identify
opportunities for enhancements and champion projects which will
improve overall site function.
- Work to minimize site costs by finding efficiencies and
synergies in the Technology Transfer process.
- Work with development and site multidisciplinary project teams
to optimize product transfers for efficient
- Remain abreast of current regulatory requirements and newest
technologies to shorten deliverable timelines and increase the
efficiencies of process while maintaining the most current
- B.S in Pharmaceutical Sciences (or equivalent) required, M.S in
Pharmaceutical Sciences (or equivalent) preferred.
- Minimum of 6 years in Sterile Product development with a focus
on Technical Transfer and commercialization. Inhalation product
experience is a MUST.
Keywords: Cameron Craig Group, Rock Hill , Process Engineer - Pharmaceuticals, Healthcare , Monroe, South Carolina
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