Manufacturing Sciences Associate

2 weeks ago

Fredericton, New Brunswick, Canada SUN PHARMA Full time
Job Summary

The Manufacturing Sciences Associate will play a key role in supporting process development studies and process validation activities at Sun Pharma. This position will be responsible for preparing technical documentation to support development and validation programs, as well as providing technical support to the Manufacturing and Quality departments.

Key Responsibilities
  • Design and execute DOE's, process optimization studies, and process qualification batches.
  • Compile and analyze process data using statistical tools.
  • Develop a strong documentation package, including process study, characterization, process qualification, and cleaning validation.
  • Prepare Master batch records, Exhibit Batch protocols, pre-validation, and process validation documentation and reports.
  • Provide troubleshooting support to manufacturing operations.
  • Champion compliance investigations, commitments (CAPA), and change controls.
  • Participate on cross-functional teams to address specific problems, facilitate discussion and research, and enhance interdepartmental relationships.
Work Environment

The Manufacturing Sciences Associate will work in an office environment located within a manufacturing/production facility. The work environment will be related to manufacturing/production environments, including:

  • Noise: Sufficient noise to cause distraction or possible injury to hearing.
  • Fumes: Smoky or vaporous emissions, usually odorous, thrown off as the result of combustion or chemical reaction.
  • Odors: Unpleasant smells.
  • Gases: Examples include carbon monoxide and ozone.
  • Dust: Airborne particles of any kind.
  • Hazards: Conditions where there is danger to life, health, or bodily injury.
Physical Requirements
  • Ability to navigate office and plant floor working environments.
  • Ability to stand, ambulate, and reach.
  • Ability to wear applicable personal protective equipment.
Education and Job Qualification
  • Minimum B.S. in a relevant science field, such as Pharmacy, Pharmaceutical Sciences, or Chemical Engineering.
  • Proficient in MS office applications (Word, Excel, Projects, PowerPoint).
  • Good interpersonal, oral communication, and technical report writing skills.
  • Analytical thinking and problem-solving skills.
  • A self-starter with a hands-on approach and a can-do attitude.
  • Intermediate-B1+ level English language proficiency.
Experience
  • Minimum one year of industry experience, ideally with solid oral dosage development.
  • Process qualification, process validation, and cleaning validation experience considered.
  • Master's degree considered in lieu of experience.

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