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PerkinElmer
PerkinElmer
5.001 – 10.000 Angajați
Sponsor pentru viza H1BAlimente și băuturiAsistență medicalăConsultanță
PerkinElmer dezvoltă soluții de analiză și testare utilizate în domeniul farmaceutic, al asistenței medicale, al alimentelor și băuturilor, al analizelor de mediu și al testării industriale. Portofoliul său include spectrometre de masă, instrumente de cromatografie, sisteme de spectroscopie, echipamente de laborator și consumabile care ajută organizațiile să evalueze materiale, să sprijine cercetarea științifică, să mențină calitatea produselor și să respecte standardele de conformitate. Cu o istorie care datează din 1938, PerkinElmer colaborează cu laboratoare și echipe din industrie din întreaga lume pentru aplicații care acoperă siguranța alimentară, testarea mediului, asistența medicală și controlul calității industriale.
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Locurile de muncă ale companiei

Senior Validation Engineer III, Lead Engineer

Lead CQV and validation work for Project Farma life sciences clients, including protocol execution, troubleshooting, and technical project delivery. Support on-site compliance and coordination across client teams.

USStatele Unite ale AmericiiCACaliforniaCOColoradoOROregonTXTexas
71.000 $ – 106.000 $ / an
La sediuNormă întreagăSeniorLimbă Obligatorie: englezăInginer full-stackInginer software

Descriere

  • Deliver technical work across life sciences projects.
  • Carry out CQV activities, including protocol development and equipment testing, under Site Lead guidance.
  • Report technical issues and help resolve them.
  • Ensure work complies with client specifications, FDA and GMP requirements, and industry standards.
  • Write SOPs, requirements specifications, testing protocols, and summary reports.
  • Execute system and process validation protocols using GxP practices.
  • Troubleshoot equipment and manufacturing processes through hands-on support.
  • Assess systems and subject areas through due diligence.
  • Identify and escalate obstacles, and develop practical solutions.
  • Support project controls and scheduling through estimates, schedules, risk reviews, forecasts, and cost analysis.
  • Coordinate with client teams in Validation, Manufacturing, Quality, Supply Chain, Engineering, and Project Controls.
  • Maintain site dashboards, deliverable trackers, and other internal tools.
  • Build technical expertise in capital project management, technology transfers, validation, quality, regulatory and compliance, GxP automated systems, and quality control.
  • Analyze project data and provide concise decision-making insights.
  • Share technical knowledge and mentor less experienced team members.
  • Take part in Project Farma’s internal qualification training program.
  • Support site strategy and carry out assigned CQV protocols.
  • Maintain working relationships with project teams and client contacts.
  • Advise on resource management and communicate workload or skills gaps.
  • Contribute to project delivery, client relationships, proposals, extensions, cross-selling, and up-selling.
  • Maintain full individual billability and escalate obstacles to meeting billable targets.

Cerințe

  • Bachelor’s degree in life science, engineering, or a related field, or equivalent experience in capital project engineering, pharmaceutical cGMP facility start-up, CapEx/OpEx project management, or comparable military experience.
  • 2–7 years of experience in consulting and/or engineering services.
  • Willingness to travel as needed for client project assignments.
  • Available for full-time, on-site work at client locations.
  • Willingness to travel up to 100% or as required.
  • Authorized to work full-time in the United States.
  • PerkinElmer does not sponsor current or future work visas.
  • Valid driver’s license.
  • Strong knowledge of CQV, system and process validation, GxP practices, and FDA and GMP requirements.
  • Able to write SOPs, requirements specifications, testing protocols, and summary reports.
  • General understanding of Earned Value Analysis and project management tools.
  • Able to support project controls and scheduling, including budgets, schedules, milestones, risks, forecasts, scenario analysis, and cost reports.
  • Able to analyze complex project data and communicate findings clearly.
  • Able to mentor junior and peer engineers.
  • Able to maintain full individual billability.

Beneficii

  • Equal opportunity employer committed to a culturally diverse workforce.
  • Opportunities for significant domestic travel.

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Sponsor pentru viza H1BAsistență medicalăConsultanțăOspitalitate
USStatele Unite ale AmericiiVAVirginiaHibridNormă întreagăSeniorLimbă Obligatorie: englezăOperațiuni

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