Davis Companieshttp://daviscos.com/wp-content/themes/davis_theme/assets/images/logo.svg325 Donald J. Lynch Boulevard, Suite 201MarlboroughMA01752USAcustomer support[+800-482-9494][+508-481-8519]
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MANUFACTURING PROCESS ENGINEER

  • Specialty:

    Engineering
    • City:

      Saint Paul
    • State:

      MN
    • 55118
  • Assignment Type:

    Direct Hire
  • Job Id:

    55451
  • Payrate:

    $48.08

Description

DAVIS Companies has partnered with a leading Manufacturing company in the Twin Cities to identify a Manufacturing Process Engineer to join their team! LOCAL candidates only please. 

Responsibilities of the Manufacturing Process Engineer:

  • Lead Design Reviews and contribute to activities in the improvement of commercial mix, coat, slitting, converting, packaging, cartoning and serialization processes for transdermal, dissolvable films and other drug products.
  • Assist and troubleshoot process / equipment issues that occur during commercial operations and product changeovers.  Including utilization and adjustments of Vision System programs and tools.
  • Based on QbD principles, plan and execute process studies for feasibility, development/characterization (DOEs), capability and qualification tied to changes on commercialized processes.
  • Through CI activities enhance process conditions that increase quality, yield or reduce set-up and tear-down activities.
  • Write specifications, R&D Mfg. instructions, protocols, SOPs, process development reports, etc.
  • Support and follow all regulatory compliance aspects, including following the necessary change control processes.
  • Lead, research and write equipment specifications with support from R&D
  • Lead  / support CI activities that increase efficiencies on commercial processes
  • Support Quality in NCM and CAPA investigations
  • Support operations with qualification / PM, commercial manufacturing activities, etc.
  • Provide technical and/or scientific guidance to operations and internal teams when appropriate.
  • Receive the hand-off of Developed Processes with robust control processes from Validation and R&D
  • Design/re-design tooling, part and packaging equipment for use in various projects
Job Qualifications of the Manufacturing Process Engineer:
  • Minimum of BS degree in science, engineering or related field, advanced degrees preferred.
  • Minimum 10 years of direct industry experience  
  • Bachelor’s degree in an Engineering or Science related field + 3 years of experience 
  • Minimum 5 years hands-on experience in manufacturing process improvement / sustainability within the pharmaceutical industry, preferably with transdermal and oral dissolvable thin film products, OR, experience with pressure sensitive adhesive processes for medical or other applications.
  • Ability to review large amounts of data/information, identify trends, draw conclusions and support a position with text and data.
  • Proven track record of planning and executing process re-development/ CI projects, and an ability to meet aggressive timelines.
  • Highly motivated individual who can work both independently and as part of a cross-functional team.???????
  • Strong technical writing and oral communication skills. Must be able to effectively communicate results or issues, verbally and in writing.
  • Knowledge and experience with cGMP for pharmaceuticals and QbD principles preferred.

Preferred Qualifications:

  • Knowledgeable and experienced with cGMP,  USP and the regulatory requirements for pharmaceuticals preferred.
  • Experience in rotary die cutting and pharmaceutical primary and secondary packaging
  • Demonstrated experience drafting Manufacturing Records, SOPs, master plans and additional protocols
  • Proven scientific and technical ability to design and execute experimental studies as well as statistically analyze data, author and review protocols and reports.
#MON
#MINN-A

Quick Apply

  • As an Equal Employment Opportunity Employer, DAVIS has reporting requirements which require us to invite employees to voluntarily self-identify their race/ethnicity. Submission of this information is voluntary and refusal to provided it will not subject you to any adverse treatment. The information obtained will be kept confidential.
  • Accepted file types: pdf, doc, docx, txt, rtf.
  • By applying to this position and providing my contact information, I give The DAVIS Companies permission to provide me with email communications and information.

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