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Process Engineering Specialist

Thermo Fisher Scientific Inc.

This is a Contract position in Vaughan, ON posted May 16, 2021.

” Thermo Fisher Scientific Inc.

is the world leader in serving science, with annual revenue exceeding $25 billion.

Our Mission is to enable our customers to make the world healthier, cleaner and safer.

Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them.

Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon.

For more information, please visit www.thermofisher.com .

How will you make an impact?

You will assist the Technical Operations department in generation of protocols, master batch record review, batch analysis, Quality Investigation Report/Quality Deviation Report (QIR/QDR) follow-up, process execution and equipment procurement.

What will you do?

Essential Functions: Quality and Technical Support: Investigates Technical Writing/Technical Operations issues (system control, Quality Investigation Report (QIR)/Quality Deviation Report (QDR) Tracks/follows-up on outstanding Corrective Action/Preventative Action (CAPA) items for the Technical Operations department Generates protocols.

Assesses and approves change controls Attends Quality Improvement meetings Assists in the coordination of project information between Account Management, Quality Assurance (QA), Quality Control (QC) and Commercial Operations Supports Technical Operations team with process execution/equipment trials and acquistion of equipment Performs batch analysis Attends key project team meetings, client teleconferences and on-site visits Master Batch Record Generation Approval: Reviews and approves processing masters.

Works closely with the Technical Operations Team and Commercial departments in the design of work orders.

Scheduling: Works closely with Technical Writers and Production supervisory staff to ensure timely completion of Commercial manufacturing activities Attends weekly scheduling meetings Mentoring: Provides training/support to co-ops (students) and monitors ongoing training How will you get there?

Education: Bachelor’s degree in Science, Engineering, or related field Experience: 2 years related experience in Master Batch Record/Protocol/Report preparation within the Pharmaceutical Industry, including proven abilities in report writing and batch record preparation required Equivalency : Equivalent combinations of education, training, and relevant work experience may be considered.

Competencies: Knowledge of current Good Manufacturing Practices and ability to follow Standard Operating Procedures.

Proficient with Microsoft Office Applications.

Proven leadership and problem solving abilities and teamwork promotion within the workplace.

Must be organized and detail oriented.

Proficient with the English language and possess excellent written and verbal communication skills.

Previous experience with Pharmaceutical Manufacturing or Quality Assurance considered an asset.

At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell.

Join us and contribute to our singular missionu2014enabling our customers to make the world healthier, cleaner and safer.