PerkinElmer
PerkinElmer
PerkinElmer izstrādā analīzes un testēšanas risinājumus, ko izmanto farmācijas, veselības aprūpes, pārtikas un dzērienu, vides analīzes, kā arī rūpnieciskās testēšanas jomās. Uzņēmuma produktu klāstā ietilpst masas spektrometri, hromatogrāfijas instrumenti, spektroskopijas sistēmas, laboratorijas aprīkojums un palīgmateriāli, kas palīdz organizācijām novērtēt materiālus, atbalstīt zinātniskos pētījumus, uzturēt produktu kvalitāti un izpildīt atbilstības standartus. PerkinElmer, kas darbojas kopš 1938. gada, sadarbojas ar laboratorijām un rūpniecības komandām visā pasaulē pārtikas drošības, vides testēšanas, veselības aprūpes un rūpnieciskās kvalitātes kontroles jomās.

Lead Validation Engineer – cGMP

Lead validation engineering work for PerkinElmer’s Project Farma life-sciences projects. Deliver CQV, system validation, and technical project support across client sites.

Apraksts

  • Complete technical work across validation and life-sciences projects
  • Deliver CQV activities, including protocol development and equipment testing
  • Document technical issues and help drive their resolution
  • Verify that deliverables satisfy client specifications, regulatory obligations, and industry standards
  • Prepare SOPs, requirements specifications, testing protocols, and summary reports
  • Carry out system and process validation protocols in accordance with GxP practices
  • Troubleshoot equipment and manufacturing processes through hands-on technical support
  • Surface project roadblocks, escalate them appropriately, and develop practical solutions
  • Support project controls and scheduling across budgets, timelines, milestones, risks, forecasts, and cost reporting
  • Share technical expertise and coach less experienced team members
  • Complete Project Farma’s internal qualification training program
  • Support site strategy and develop and execute CQV protocols
  • Build effective working relationships with project teams and client contacts
  • Help advance project-level business development, proposals, and client deliverables
  • Maintain full individual billability and escalate issues that could affect billable targets

Prasības

  • 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 work
  • Up to eight years of experience in consulting and/or engineering services
  • Ability to travel as required for client project assignments
  • Ability to travel up to 100% or as required
  • Authorization to work full-time in the United States
  • This role does not offer current or future work visa sponsorship
  • Valid driver’s license
  • Knowledge of cGMP, GxP, FDA requirements, and applicable industry standards
  • General familiarity with Earned Value Analysis and project management tools
  • Technical expertise in CQV, system and process validation, protocol development, equipment testing, SOPs, requirements specifications, and summary reports

Priekšrocības

  • Full-time presence at client sites
  • Travel opportunities supporting client projects and business needs

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