06 Sep, 2021

Process Engineering Specialist II

  • Thermo Fisher Scientific
  • Whitby, ON, Canada
Process Engineer Chemicals

Job Description

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 mission—enabling our customers to make the world healthier, cleaner and safer. 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 support 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:

  • Technology transfer. Responsible for transfers and launches to the site. Includes process scale-up and process optimization.
  • Investigates quality issues could include system control, Quality Investigation Report (QIR)/Quality Deviation Report (QDR).
  • Investigates root causes and recommends appropriate Corrective Action/Preventative Action (CAPA) items for the Technical Operations department (using tools such as FMEA, RCA, etc).
  • Generates technical documents (protocols, reports, proposals, gap/risk assessment, batch records, URS, etc).
  • Generates, 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 design and acquisition of equipment.
  • Performs batch analysis.
  • Attends project team meetings, client teleconferences and on-site visits.
  • Daily interactions with clients.
  • Works closely with Technical Writers and Production supervisory staff to ensure timely completion of Commercial manufacturing activities and attends weekly scheduling meetings (if applicable).
  • Provides training/support to Co-Ops/Interns and monitors ongoing training (if applicable).
  • Performs alternating or rotating shifts (as the need arises).

How will you get here?

REQUIRED QUALIFICATIONS

Education:

  • Minimum post secondary diploma in Chemistry, Engineering, Science or related field.
  • BSc in Chemistry or Engineering is an asset.

Experience:

  • Minimum 3 years of experience within Pharmaceutical Manufacturing or Quality Assurance departments
  • Minimum 2 years of combined hands on pharmaceutical experience in Production and Development (scale up and technology transfer of solids and liquids).
  • Minimum 1 year experience in Master Batch Record/Protocol/Report preparation within the Pharmaceutical Industry, including proven abilities in report writing and batch record preparation required
  • Previous experience in statistical analysis and data compilation an asset.
  • Previous experience with SAP enterprise software to source information and navigate business operations an asset.

Equivalency:

Equivalent combinations of education, training, and relevant work experience may be considered.

Knowledge, Skills and Abilities:

  • Knowledge of processing/packaging equipment.
  • Knowledge of current Good Manufacturing Practices and ability to follow Standard Operating Procedures.
  • Detail oriented and organized, with a high degree of accuracy and thoroughness.
  • Excellent interpersonal and communication skills.
  • Ability to multi-task, meeting tight deadlines in a fast paced environment.
  • Proven problem solving abilities.
  • Demonstrated computer proficiency with Microsoft Office programs.
  • Proficiency with the English Language.

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 mission—enabling our customers to make the world healthier, cleaner and safer.


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