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2 дня назад

Senior System Specialist

99 200 - 165 400$
Формат работы
onsite
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
Senior System Specialist (Instrumentation and cGMP Systems): Supporting the lifecycle of quality control and GMP manufacturing instruments at the Andover site with an accent on validation, qualification, maintenance, troubleshooting, and data integrity. Focus on leading complex instrumentation projects, resolving system performance issues, and authoring technical and compliance documentation.

Location: On-premise in Andover, Massachusetts, United States. First shift, Monday through Friday, with occasional off-hour support for time-sensitive production and business issues. Permanent U.S. work authorization is required; U.S. work visa sponsorship is not available.

Annual base salary: $99,200–$165,400, plus a 12.5% bonus target and eligibility for a share-based long-term incentive program.

Company

hirify.global develops and manufactures pharmaceutical and healthcare products, with this role supporting quality control laboratories and GMP manufacturing operations.

What you will do

  • Support hardware and software installation, configuration, maintenance, troubleshooting, backup, restoration, virtualization, and new system setup for regulated instruments and workstations.
  • Lead instrumentation lifecycle, validation, qualification, upgrade, reliability, maintenance, system administration, and decommissioning projects.
  • Resolve moderate- to high-impact instrumentation issues in collaboration with Quality Control and GMP Manufacturing teams.
  • Provide vendor and IQ/OQ/PQ support and contribute to network-related initiatives.
  • Author and review validation, operating, maintenance, administration, data integrity, electronic records, reconciliation, change control, investigation, and corrective action documentation.
  • Work independently, exercise technical judgment, and guide lower-level team members.

Requirements

  • Bachelor’s degree with at least 4 years of experience, master’s degree with at least 2 years, PhD with 0+ years, associate’s degree with 8 years, or high school diploma/equivalent with 10 years of relevant experience.
  • Experience supporting software, hardware, computer systems, and instrument lifecycle processes in a regulated environment.
  • Experience with quality control or manufacturing instrument validation, maintenance, or decommissioning.
  • Knowledge of cGMP principles, data integrity, ERES requirements, 21 CFR Part 11, ICH, and Annex 11.
  • Experience with VLANs, network security protocols, firewalls, server configuration, virtualization, and Microsoft operating system troubleshooting.
  • Must have permanent authorization to work in the United States; visa sponsorship is not available.

Culture & Benefits

  • On-premise work supporting office, laboratory, and GMP manufacturing areas.
  • Comprehensive medical, prescription drug, dental, and vision coverage.
  • 401(k) matching contributions and an additional retirement savings contribution.
  • Paid vacation, holidays, personal days, caregiver/parental leave, and medical leave.
  • Relocation assistance may be available based on business needs and eligibility.

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