Process Engineer

Sun Pharmaceutical IndustriesChattanooga, TN
54d$101,000 - $112,500Onsite

About The Position

This position will provide engineering designs and recommendations for assigned processes and new technologies to develop the most cost effective solutions for manufacturing.

Requirements

  • BS in Chemical Engineering.
  • 5 years experience with FDA/GMP. Experience with DEA guidelines and regulations a plus.
  • Excellent organization skills.
  • Ability to present ideas effectively to all levels of management.

Responsibilities

  • Prepare, review, approve and distribute the instructions for the production of intermediates or APIs, according to written procedures.
  • Produce APIs and intermediates according to preapproved instructions;
  • Review all production batch records and ensure that these are completed and signed.
  • Report and evaluate all production deviations and ensure that all critical deviations are investigated (with the conclusions recorded).
  • Ensure that production facilities are clean and disinfected;
  • Ensure that all necessary calibrations are performed (with records kept)
  • Maintain the premises and equipment (with records kept).
  • Ensure that validation protocols and reports are reviewed and approved;
  • Evaluate proposed changes in product, process or equipment.
  • Responsible for ensuring that new and modified facilities and equipment are qualified.
  • Review and analyze manufacturing needs, formulate solutions and implement changes to optimize manufacturing processes.
  • Manage assigned projects in order to complete each project on time, under budget and within the design parameters.
  • Provide training for API processes.
  • Other duties as assigned.

Benefits

  • Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program.
  • Employees also receive various paid time off benefits, including vacation time and sick time.
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