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.
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.
Descriere
- 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
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 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
Beneficii
- Full-time presence at client sites
- Travel opportunities supporting client projects and business needs