Process Engineering Specialist II

October 23 2021
Industries Pharmaceutical, Biotechnology
Categories Automation, Process, Chemistry, Engineering, Trades, Technicians, Construction
Whitby, ON

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

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?

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.
  • Strong written and oral skills.
  • 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.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one global team of 90,000 colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

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