5 001 – 10 000 Қызметкерлер
H1B визасының демеушісіАзық-түлік және сусындарДенсаулық сақтауКонсалтингPerkinElmer фармацевтика, денсаулық сақтау, тамақ және сусын өндірісі, қоршаған ортаны талдау және өнеркәсіптік сынақ салаларында қолданылатын аналитикалық және сынақ шешімдерін әзірлейді. Оның өнімдер портфеліне масс-спектрометрлер, хроматография аспаптары, спектроскопия жүйелері, зертханалық жабдықтар және шығын материалдары кіреді. Бұл шешімдер ұйымдарға материалдарды бағалауға, ғылыми зерттеулерді қолдауға, өнім сапасын сақтауға және сәйкестік стандарттарын орындауға көмектеседі. Тарихы 1938 жылдан басталатын PerkinElmer азық-түлік қауіпсіздігі, қоршаған ортаны сынау, денсаулық сақтау және өнеркәсіптік сапаны бақылау сияқты түрлі бағыттарда бүкіл әлемдегі зертханалармен және өнеркәсіптік топтармен жұмыс істейді.
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.
Сипаттама
- 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.
Талаптар
- 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.
Артықшылықтар
- Equal opportunity employer committed to a culturally diverse workforce.
- Opportunities for significant domestic travel.