Role: Senior MSAT Engineer
Location: Tampa, Florida
DSJ Global is currently partnered with an industry leading biotechnology company specializing the optimization of scientific innovation and manufacturing technology to support healthier lifestyles. With the continuous contribution to scientific innovation, this company is looking to expand its team with a Senior MSAT Engineer. Based in Tampa, Florida, this company will provide an engaging dynamic combined with a fast-paced work environment. If you are a self-motivated and intellectually curious individual, don't wait - apply now!
In this role, you will have the following responsibilities:
- Performs all MSAT functions associated with process transfer, batch record drafting and process support of small molecule
- Perform process monitoring (manufacturing data summary and analysis, data presentation), author campaign summary, perform activities for lot release (assess deviations and process changes), and continued process verification activities.
- Provide guidance on process transfer and support activities to junior members of the team.
- Assess all major deviations for impact product quality.
- Authors / present training presentations to manufacturing and other departments.
- Effectively work with other departments and interface with customers.
- Engagement of internal and external technical teams to facilitate successful technical transfers of product processes
- Directly involved with customers to ensure projects are planned and executed appropriately in order to deliver to and meet the needs of our customers and the business
The Senior MSAT Engineer should have the following qualifications:
- Bachelor of Science degree in Biological Sciences or Biomedical/Chemical Engineering. Masters of Science or Engineering or PhD highly preferred.
- Extensive small molecule industry experience in process scale up/manufacturing and process validation
- Experience with Good Manufacturing Practice (GMP) and manufacturing support (Oral Solid Dose)
- US/EU regulations and intermediate knowledge of statistical data analysis
- Effectively presents information and ideas formally and informally, verbally and in writing to others in a manner that facilitates understanding.
- Able to concisely communicate status, needs, forecasts, risks and timelines effectively to senior management
- Excellent attention to detail, with ability to prioritize and be flexible in managing change, anticipating and resolving complex technical and business problems with ability to positively impact customer relationships and external technical network
- Displays a clear willingness to listen to others. Has good interpersonal skills and works collaboratively in an effective manner to achieve objectives.