Antares Pharma: Making Medicines Feel Better

Manufacturing Engineer II

POSITION SUMMARY

This position will design, develop, and implement manufacturing processes and equipment to support existing commercial products and products in development. Processes and equipment may be located within Antares or within contract manufacturer site.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Responsibilities include, but are not limited to:

  • Translate device design requirements into process and equipment and manufacturing requirements that meet Regulatory and Quality requirements
  • Provide support and expertise to new and existing manufacturing processes, troubleshoot line issues
  • Collaborate on device designs to ensure manufacturability and automated packaging solution
  • Lead and collaborate FMEAs (process/design, respectively) to identify and reduce risk
  • Develop, execute, and document equipment qualifications and process validations, including master validation plans/reports and IQ, OQ, PQ plans/reports
  • Develop, implement, and support production documentation including manufacturing procedures, routers, and bill of materials (BOM)
  • Provide engineering support to customers, equipment suppliers, and contract manufacturers
  • Utilize tools including measurement system analysis (MSA), gage repeatability and reproducibility (GRR), design of experiments (DOE), statistical process control (SPC), and capability analysis to develop and control processes
  • Support test method and inspection method development/validation used during design verification, process validation, and commercial manufacturing
  • Utilize tools including value stream mapping, overall equipment effectiveness (OEE), and 5S to understand and improve quality, labor efficiency, throughput, and cycle time
  • Develop project timelines, scope of work, and other project documents to ensure cross-functional/cross-company alignment and project success
  • Provide project communication to team members, customers, contract manufacturers, and stakeholders
  • Support product complaint investigations and reports
  • Support CAPA/NCR/SCAR investigations and reports

EDUCATIONAL REQUIREMENTS(degree, license, certification:

  • Bachelor level degree in Engineering or related Science

YEARS OF EXPERIENCE:

  • 3-6 years relevant experience within the medical device or pharmaceutical industry supporting commercial production
  • 2+ years of automated and manual medical assembly experience

OTHER SKILLS AND ABILITIES:

  • Experience with medical device or pharmaceutical product manufacturing
  • Experience with manual, semi-automated, and fully automated assembly and packaging processes
  • Experience with equipment specifications
  • Experience with manufacturing process instructions
  • Excellent written skills including technical protocols/reports
  • Ability to communicate and educate internally and externally (product builders, cross-functional team members, suppliers, customers, stakeholders, regulatory agencies)
  • Knowledge of GMP, CFR, ISO, QSR and other regulations, standards, directives and guidance
  • Experience with computer software including Minitab, Project, Excel/Word, Solidworks, Master Control
  • Experience with statistical tools, data analysis, and Six Sigma methodology
  • Hands on experience with assembly (manual and automated) equipment
  • Ability to solve problems, troubleshoot, and improve processes and equipment
  • Ability to manage multiple projects and work independently or in cross-functional team environment
  • Ability to lift 30lbs
  • Travel up to 30% (domestic & international)

We are not accepting solicitations from Recruiters or Consultants at this time.

APPLY TO: Careers@Antarespharma.com

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