29.10.26

Device Assembly & Packaging Engineer

  • Permanent
  • USA
  • CDMO

Device Assembly & Packaging Engineer

WHO?:

The Technical Services and Manufacturing Sciences (TSMS) Device Assembly and Packaging Engineer will be responsible for supporting device assembly and packaging development across all facets of Tech transfer, Process Validation, GMP Floor Support, and Continued Process Verification in accordance with current good manufacturing practices (cGMP) for clinical and commercial programs. This role will provide technical support for secondary manufacturing operations to ensure robust and reliable packaging and device assembly processes are established and executed.

There is a growing need globally for more CDMOs (contract development and manufacturing organization) in the pharmaceutical industry to provide comprehensive services from drug development through drug manufacturing.

At INCOG, they are more than just a CDMO. A better way to create more meaningful experiences. A better way to create a culture that everyone can thrive and succeed in. At their core, that is who they are—a dedicated team that believes they can always be better.

Join the team at INCOG, a world-class CDMO for parenteral injectable drugs, shaping a new future for patients, for yourself, and for INCOG’s clients.

WHAT?:

  • Execute early packaging (primary, secondary, and tertiary) and/or device assembly development activities in a cross-functional team.
  • Meet with client team to understand packaging requirements and develop technical documentation such as Technical Transfer Plan, Process Flow Diagrams (PFD), Gap Assessment, Summary Reports and Process FMEA.
  • Recognized as Subject Matter Expert for the device assembly and packaging processes.
  • Monitor Process Data, identify trends and propose actions as necessary.

YOU:

Ideally, candidates will have a Bachelor’s (& Master’s preferred) degree in Science (Biology, Chemistry, Pharmaceutical Sciences, Engineering, etc), as well as the following:

  • Demonstrated experience in the field of pharmaceutical packaging or combination product development and commercialization.
  • Experience in Technical Transfer for pharmaceutical or related industry.
  • Functional knowledge of regulatory requirements and industry guidance applicable to CGMPs for Combination Products, including 21 CFR Part 4 Regulation of Combination Products and FDA Guidance for Industry: Current Good Manufacturing Practice Requirements for Combination Products (2015), and ISO 13485:2016 Medical devices — Quality management systems.

Why INCOG?

  • Paid vacation days, amount based on tenure, and paid sick time
  • PTO (based on tenure) & 11 holidays (9 observed + 2 floating)
  • 401(k) plan with company match up to 3.5% of salary, vested immediately
  • Choice of health & wellness plans
  • FSA and HSA programs
  • Dental & vision care

Interested? Send us your resume at apply@leadcandidate.com or you can find more information here: DAP Engineer – INCOG

Lead Candidate wholeheartedly supports Equality and Diversity in employment and opposes all forms of unlawful or unfair discrimination on the grounds of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.

Apply here
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