Principal Engineer (Pharmaceutical Engineering)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
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
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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