Specialist, MS&T

Emergent BioSolutions; Winnipeg; On-site; CAD 85,000 - 110,000; Full time

Job summary

Emergent BioSolutions seeks a Specialist in MS&T for our Winnipeg site to support production, troubleshooting, deviations, CAPAs, data trending, and batch record management.

The role emphasizes cross-functional collaboration, problem solving, and applying continuous improvement methods to enhance manufacturing processes and equipment performance.

Qualifications

• Bachelor’s degree in Engineering, Science or related field preferred; equivalent considered.
• 5+ years in process engineering or related field including ops support and troubleshooting.
• Strong understanding of industry standards and best practices.
• Ability to solve problems and analyze data to derive guidance.
• Strong technical writing and oral communication skills.
• Familiarity with Operational Excellence tools such as lean manufacturing and Gemba walks.

Responsibilities

• Leads resolution of production process concerns including troubleshooting, investigations, data review and CAPAs.
• Identifies and implements improvements to equipment, techniques, materials, and processes.
• Authors batch records and SOP creation/changes.
• Performs statistical process control with routine data trending and root cause analysis.
• Acts as SME for quality investigations of process deviations.
• Conducts Gemba walks to identify improvements in equipment and processes.
• Facilitates cross-functional brainstorming to explore all options.
• Supports qualification activities and studies for continuous improvement projects.
• Evaluates transfer of process development recommendations into operations.

Skills

Troubleshooting

CAPAs

Data trending

Gemba walks

Root cause analysis

Lean manufacturing

Problem solving

Cross-functional collaboration

Statistical analysis

Technical writing

Oral communication

Education

Bachelor’s degree in Engineering or Science

Tools

Microsoft Office

Job description

Preparedness today, safer tomorrow. Emergent is a leading public health company that delivers protective and life-saving solutions to communities 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 - THIS IS A TERM POSITION

The Specialist, MS&T role is a member of the Manufacturing Sciences & Technology (MS&T) department that provides technical expertise and support to production (manufacturing, aseptic filling, and packaging departments). As such, this role is responsible for supporting and conducting troubleshooting, investigations, reviewing deviations, executing corrective and preventative actions (CAPAs), data trending, protocol and report generation, and batch record authoring/editing.

Responsibilities

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

• Leads the resolution of production process concerns including troubleshooting, investigations, data review and analysis, execution of CAPAs, etc.
• 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 completing routine data trending and root cause analysis.
• Acts as lead / subject matter expert (SME) for quality investigations of process related deviations.
• Conducts in Gemba walks by identifying, recommending, and implementing improvements to equipment, techniques, materials, and processes as required.
• Facilitates cross-functional brainstorming sessions to direct the flow of information and ensure all avenues are explored.
• Supports with qualification activities and studies associated with continuous improvements projects. This could include generation of protocols and reports, assessment of data, and protocol execution.
• Evaluate and transfer of process development recommendations into operations.

The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.

Education, Experience & Skills

• Bachelor’s degree in Engineering, Science or related field is preferred; an equivalent level of education, skills, and experience will be considered.
• 5+ years of experience in process engineering or related field including operations support and troubleshooting.
• Strong understanding of industry standards and best practices.
• Demonstrated ability to conduct problem solving and analysis of data to derive conclusions and deliver guidance.
• Strong technical writing and oral communication skills.
• Strong understanding of Operational Excellence and Continuous Improvement methodologies and tools such as lean manufacturing, 6S, 8 wastes, Gemba walks, tiered meetings, etc.
• Ability to apply knowledge, innovation, and a continuous improvement focus to activities.
• Ability to work independently, while maintaining positive, collaborative relationships cross-functionally.
• Proficient in Microsoft office including Excel, Word, Outlook, Teams, and PowerPoint.

There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.

As part of our team, you'll join talented and inspiring colleagues whose sense of purpose complements your own. We offer highly diverse career opportunities, a supportive culture, competitive salaries, flexible work arrangements and an extensive benefits package. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy.