Specialist, MS&T

Emergent Biosolutions•Winnipeg, MB

49d

About The Position

Emergent is a leading public health company that delivers protective and life-saving solutions tocommunities around the world. Here, you will join passionate professionals where our culture is informed by our values and commitment to protecting and saving lives.Job Summary The Specialist, MS&T role is a member of the Manufacturing Sciences & Technology (MS&T) department providing technical expertise to support Production (manufacturing, aseptic filling, and packaging departments). It also includes the support of internal / external Technology Transfers of new products/processes for both clients and Emergent. The role includes participating in troubleshooting, investigations, reviewing deviations, executing corrective and preventative actions (CAPAs), data trending, protocol and report generation, and batch record authoring/editing to support the successful manufacture of commercial products.

Requirements

Bachelor’s degree in science, Engineering or related field is strongly preferred; an equivalent level of education, skills, and experience will be considered.
Extensive Knowledge of cGMP and process validation along with expertise in manufacturing processes and design, supporting technology transfer.
10+ years of experience in pharmaceutical manufacturing / process engineering or related field including operations support and troubleshooting.
Demonstrated ability to conduct problem solving and analysis of data to derive conclusions and deliver guidance.
Strong technical writing and oral communication skills and knowledge of Microsoft Office Suite of Products.
Ability to work independently, while maintaining positive, collaborative relationships cross-functionally.

Responsibilities

Supports the Transfer of new processes into the manufacturing site for subsequent qualification and validation for potential commercialization
Supports the evaluation and transfer of process development recommendations into operations.
Participates in cross-functional brainstorming sessions to direct the flow of information and ensure all avenues are explored
Provides subsequent troubleshooting, investigations, data review and analysis, execution of CAPAs, etc. on commercialized processes
Identifies, recommends, and implements improvements to equipment, techniques, materials, and processes.
Authors batch record and standard operating procedure creation and changes.
Conducts statistical process control by supporting routine data trending and root cause analysis.
Acts as a subject matter expert (SME) for quality investigations of process related deviations.
Participates in Gemba walks by identifying, recommending, and implementing improvements to equipment, techniques, materials, and processes as required.
Supports qualification activities and studies associated with continuous improvements projects. This could include generation of protocols and reports, assessment of data, and protocol execution.