Senior System Specialist
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
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
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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