System Specialist (Pharmaceutical Manufacturing)

Location: On-premise in Andover, Massachusetts, United States. First-shift schedule, Monday through Friday, with occasional off-hours support for time-sensitive production and business issues.

Annual base salary: $82,700–$137,900, plus eligibility for a 10% bonus target.

Company

hirify.global develops and manufactures pharmaceutical products and operates regulated quality control and GMP manufacturing environments.

What you will do

• Support the quality control and manufacturing instrumentation lifecycle program, including installation, configuration, maintenance, troubleshooting, backup, restoration, and system setup.
• Provide vendor, IQ/OQ/PQ, validation, qualification, upgrade, reliability, operation, and decommissioning support for cGMP instruments and workstations.
• Support kiosk-mode software, data protection solutions, data virtualization, system administration, and electronic data reconciliation activities.
• Provide project management and technical support for instrumentation processes, performance issues, continuous improvement initiatives, and site projects.
• Author and review validation documents, procedures, periodic reviews, data integrity assessments, change controls, investigations, corrective actions, and decommissioning documentation.
• Collaborate with Quality Control and GMP Manufacturing teams to resolve moderately complex instrumentation issues.

Requirements

• Bachelor’s degree with at least 2 years of experience, master’s degree with 0+ years, associate’s degree with 6 years, or high school diploma/equivalent with 8 years of relevant experience.
• Experience supporting software, hardware, computer systems, and instrument lifecycle processes in a regulated environment.
• Knowledge of quality control or manufacturing instrumentation validation, maintenance, or decommissioning is preferred.
• Knowledge of cGMP principles, data integrity, ERES requirements, 21 CFR Part 11, ICH, or Annex 11 is preferred.
• Experience with VLANs, network security protocols, firewalls, server configuration, virtualization, Microsoft operating systems, Windows registry, and system files is preferred.
• Candidates must have permanent authorization to work in the United States. U.S. work visa sponsorship is not available.

Culture & Benefits

• Full-time employment with comprehensive health, 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.
• Work is performed in office, quality control laboratory, and GMP manufacturing areas.