Manufacturing Engineer II (pharmaceutical or regulated experienc

Published
September 24, 2021
Location
West Point, PA
Category
Job Type

Description

Duration - 12 months long project with possibility of extesnion

Pay - $35/hr to $39/hr

Qualifications:

  • The ideal candidate would possess BS in Chemical, Biochemical, Biomedical engineering or a BS in the life sciences.
  • Entry level resources w/1-3 years of experience in the pharmaceutical/regulated industry is preferred – Direct or technical operations roles.
  • Strong understanding/advanced knowledge of GMP/engineering documentation practices and design requirements for cGMP process.
  • Familiar W/ Trackwise and or Change Control systems, multivariate data analysis tools, deviation management systems and process, CAPA investigations, batch record generation and review.
  • Technology transfer experience a plus.
  • Authoring/reviewing technical memo’s and reports. 3 years of experience writing change controls.
  • Experience working with CMO's, project management skills/experience.
  • Data focused - Data entry & data analysis. Phone/meeting/WebEx/Teams

Responsibilities:

  • Execute manufacturing process change controls as part of product lifecycle.
  • Investigate manufacturing deviations to determine root cause and ensure Corrective and Preventative Actions (CAPAs) are implemented. Perform data monitoring and trending.
  • Provide filing/submission support by source documentation mapping and data audits. Author reports/ technical documents as needed.
  • Join calls with CMO's, data monitoring group, supporting team through campaign readiness, run business activities for commercial management manufacturing.
  • Deviation management.
  • There are approximately 10 people on the team who are very collaborative and work well together. The team is expanding.
  • Work with cross functional teams to develop & improve manufacturing systems to support utilizing cGMP process equipment while maintaining and improving quality standards. Develop or revise technical related forms and documents for process and manufacturing equipment.
  • Schedule and oversee the performance of preventive maintenance work orders of cGMP equipment.
  • Implements corrective/preventive actions for existing equipment and manufacturing processes.
  • Prepare change control documentation. Write and modify procedures for the proper operation of new and/or existing equipment. You will also manage external partnerships.

To apply for this position, click on apply and send in your resume along with your contact info. For any further queries please feel free to contact:

Kajal Jyotishi; 973-878-4297; [Click Here to Email Your Resumé]

cGMP process,technical operations,deviation management,CAPA investigations, batch record,Technology transfer experience,change controls

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