Pharma Process Engineer – GMP & Process Optimization

SUN PHARMA

Chattanooga (TN)

On-site

USD 90,000 - 120,000

Full time

3 days ago
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Job summary

SUN PHARMA in Chattanooga, TN is seeking an engineer to design and optimize manufacturing processes for intermediates and APIs. You will develop cost-effective solutions and lead cross-functional projects to improve efficiency, quality, and compliance.

Responsibilities include preparing and reviewing production instructions, overseeing batch records, validating calibrations, and training staff on API processes.

Qualifications

  • BS in Chemical Engineering.
  • 5 years experience with FDA/GMP; DEA guidelines knowledge a plus.
  • Ability to present ideas effectively to all levels of management.

Responsibilities

  • Prepare, review, approve and distribute production instructions for intermediates/APIs.
  • Produce APIs/intermediates according to preapproved instructions.
  • Review batch records to ensure completion and signature.
  • Report and evaluate production deviations; investigate critical deviations.
  • Ensure production facilities are clean and disinfected.
  • Ensure calibrations are performed with proper records.
  • Maintain premises and equipment with records kept.
  • Review and approve validation protocols/reports.
  • Evaluate proposed changes in product, process or equipment.
  • Ensure that new/modified facilities and equipment are qualified.
  • Review manufacturing needs, formulate solutions and implement process changes.
  • Manage assigned projects to finish on time, under budget, within design parameters.
  • Provide training for API processes.
  • Other duties as assigned.

Skills

Presentation
Communication

Education

BS in Chemical Engineering

Job description

SUN PHARMA in Chattanooga, TN is seeking an engineer to design and optimize manufacturing processes for intermediates and APIs. You will develop cost-effective solutions and lead cross-functional projects to improve efficiency, quality, and compliance.

Responsibilities include preparing and reviewing production instructions, overseeing batch records, validating calibrations, and training staff on API processes.

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