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Patheon
Process Engineering Specialist [RR#2017-66]
Toronto - Canada
Posted April 21, 2017

Join us as We Transform How Pharmaceuticals are Made.

Patheon is looking for people who are passionate about making a difference in people’s lives. Patheon is in need of proven leaders to nurture talent, build effective teams and drive engagement in an environment where people are motivated to do their best for the company, its clients and their patients. To inspire collaboration and innovation.
Summary

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

Key Requirements

Quality and Technical Support:

  1. Investigates Technical Writing/Technical Operations issues (system control, Quality Investigation Report (QIR)/Quality Deviation Report (QDR)

  2. Tracks/follows-up on outstanding Corrective Action/Preventative Action (CAPA) items for the Technical Operations department

  3. Generates protocols.

  4. Assesses and approves change controls

  5. Attends Quality Improvement meetings

  6. Assists in the coordination of project information between Account Management, Quality Assurance (QA), Quality Control (QC) and Commercial Operations

  7. Supports Technical Operations team with process execution/equipment trials

  8. Performs batch analysis

  9. Attends key project team meetings, client teleconferences and on-site visits

     

    Master Batch Record Generation Approval:

  1. Reviews and approves processing and packaging masters.
  2. Works closely with the Technical Operations Team and Commercial departments in the design of work orders.

 

Scheduling:

  1. Works closely with Technical Writers and Production supervisory staff to ensure timely completion of Commercial manufacturing activities
  2. Attends weekly scheduling meetings

 

Mentoring:

  1. Provides training to new Technical Writers and monitors ongoing training to current Technical Writers as required
  2. Other duties as assigned.
Qualifications

Education:

Degree in Science, Engineering, or related field

 

Experience:  

2 years related experience in Master Batch Record 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.

Help Us Make a Healthier World.

Patheon provides development and manufacturing services for more than 800 pharmaceuticals, including nearly a fifth of the world’s top selling drugs. We’ve helped our clients earn more than twice as many U.S. FDA approvals than any other CDMO. Are you as committed as we are to exceeding expectations with high-quality solutions to complex problems? If so, we want to talk to you about making a healthier world... together. Join us at patheon.com
Disclaimer

Patheon Inc. is an equal opportunity employer and is committed to the principle of diversity and is particularly interested in receiving applications from a broad spectrum of people. Accommodations for job applicants with disabilities are available upon request.

 

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