PerkinElmer kuria analizės ir bandymų sprendimus, naudojamus farmacijos, sveikatos priežiūros, maisto ir gėrimų, aplinkos analizės bei pramoninių bandymų srityse. Įmonės asortimentą sudaro masės spektrometrai, chromatografijos prietaisai, spektroskopijos sistemos, laboratorinė įranga ir eksploatacinės medžiagos, padedančios organizacijoms vertinti medžiagas, remti mokslinius tyrimus, užtikrinti gaminių kokybę ir laikytis atitikties standartų. Nuo 1938 metų veikianti „PerkinElmer“ visame pasaulyje bendradarbiauja su laboratorijomis ir pramonės komandomis maisto saugos, aplinkos tyrimų, sveikatos priežiūros ir pramoninės kokybės kontrolės srityse.
Senior CQV Validation Engineer III
Deliver commissioning, qualification, and validation work for life sciences clients, including equipment testing and GxP validation. Support project controls, technical delivery, client relationships, and billability.
Aprašymas
- Deliver technical work and project deliverables across life sciences engagements.
- Carry out commissioning, qualification, and validation activities, including protocol development and equipment testing, with Site Lead guidance.
- Flag technical issues and help resolve them.
- Meet client specifications, regulatory requirements, and industry standards.
- Write SOPs, requirements specifications, test protocols, and summary reports.
- Execute system and process validation protocols in line with GxP practices.
- Troubleshoot equipment and manufacturing processes with hands-on support.
- Conduct due diligence on systems and subject areas.
- Identify and escalate obstacles and develop practical solutions.
- Assist with project controls and scheduling, including budgets, schedules, milestones, risks, forecasts, and cost reports.
- Coordinate with Validation, Manufacturing, Quality, Supply Chain, Engineering, and Project Controls teams.
- Keep site dashboards, deliverable trackers, and other internal tools up to date.
- Review project data and provide concise insights for decisions.
- Mentor less experienced colleagues and share technical expertise.
- Contribute to site strategy and complete assigned CQV protocols.
- Build and maintain relationships with project teams and client contacts.
- Advise the Site Lead on resource needs and workloads.
- Contribute to project outcomes, proposals, extensions, and client deliverables.
- Present Project Farma services to clients and identify opportunities for additional services.
- Meet the 100% individual billability target and raise barriers that could affect it.
Reikalavimai
- 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.
- 2–7 years of experience in consulting and/or engineering services.
- Able to travel as required for client assignments, potentially up to 100%.
- Available to work full time on site at client locations.
- Authorized to work full time in the United States; visa sponsorship is not available.
- Valid driver’s license.
- Technical knowledge of CQV, system and process validation, GxP practices, FDA requirements, and GMP requirements.
- Able to write SOPs, requirements specifications, test protocols, and summary reports.
- General understanding of Earned Value Analysis and project management tools.
- Able to support project controls, scheduling, budgets, milestones, forecasts, risks, and cost analysis.
- Able to analyze complex project data and communicate findings clearly.
- Able to mentor junior and peer engineers.
- benefits an array
- Equal opportunity employer
Privalumai
- Equal opportunity employer
- Culturally diverse workforce
- Full-time employment