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1 день назад

Principal Engineer (Pharmaceutical Engineering)

Формат работы
onsite
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

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TL;DR

Principal Engineer (Pharmaceutical Engineering): Serving as the site technical authority for process equipment design and facility integration at a drug product manufacturing site. Focus on leading complex design decisions, multidisciplinary troubleshooting, and lifecycle technical support for Oral Solid Dosage (OSD) systems from construction through routine operations.

Location: On-site in Middletown, DE

Company

hirify.global is a global provider of R&D and manufacturing services that enable the pharmaceutical, biotech, and medical device industries to advance discoveries and deliver treatments to patients.

What you will do

  • Serve as the site technical design authority for OSD manufacturing and packaging equipment.
  • Review and approve equipment layouts, 3D models, P&IDs, and utility requirements.
  • Lead multidisciplinary design reviews and resolve interface gaps between vendors, contractors, and internal teams.
  • Provide senior technical oversight during FAT, SAT, commissioning, and qualification.
  • Lead complex troubleshooting, root-cause investigations, and deviation support for manufacturing systems.
  • Mentor equipment engineers and support the development of internal site engineering capabilities.

Requirements

  • Bachelor's degree in Chemical, Mechanical, or Pharmaceutical Engineering with 12+ years of relevant experience (or Master's/PhD with equivalent experience).
  • Extensive experience with pharmaceutical process equipment and equipment-to-facility integration.
  • Strong background in supporting greenfield facilities, major capital projects, and equipment start-up.
  • In-depth understanding of cGMP engineering practices, design control, and equipment lifecycle documentation.
  • Proven ability to lead cross-functional technical decisions and resolve complex engineering problems.
  • Must be able to work on-site in Middletown, DE.

Nice to have

  • Experience in a CDMO/CMO environment.
  • Knowledge of high-containment equipment (OEB3/OEB4) and material-handling systems.
  • Working knowledge of process automation, equipment controls, and serialization.
  • Professional certifications such as PE, PMP, or Lean Six Sigma.

Culture & Benefits

  • Opportunity to lead technical workstreams in a high-impact pharmaceutical manufacturing environment.
  • Engagement with complex, large-scale capital projects and facility expansions.
  • Collaborative environment working with cross-functional teams including Quality, EHS, and Operations.
  • Focus on continuous improvement, reliability, and total cost of ownership.

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