Principal Automation Engineer (Pharmaceutical Manufacturing)

Location: US-CO-Frederick

Salary: $146,640–$229,125 per year, plus eligibility for bonus, stock, and benefits.

Company

hirify.global provides instruments, services, consumables, applications, and expertise for life science, diagnostic, and applied market laboratories, including pharmaceutical and biopharmaceutical manufacturing solutions.

What you will do

• Lead automation activities for a large-scale greenfield pharmaceutical manufacturing expansion.
• Evaluate and recommend automation integration, distributed control, and plant control platforms for the new facility.
• Define requirements for process control, bioprocessing skids, building management systems, plant data historians, and IT/OT infrastructure.
• Develop MES and integration requirements, including process data collection for Electronic Batch Records.
• Manage contract resources supporting automation integration, data historians, and MES integration.
• Support commissioning, qualification, and validation activities as the primary automation point of contact.

Requirements

• Bachelor’s or master’s degree, or equivalent experience; postgraduate qualifications, certification, or licensing may be required.
• 10+ years of relevant experience in a leadership position.
• Knowledge of GMP, GAMP, GDP, data integrity, 21 CFR Part 11, and qualification of biopharmaceutical GMP computerized systems.
• Knowledge of computer hardware, networking, operating systems, integrated architectures, cybersecurity, and system resiliency.
• Knowledge of automation standards including ISA-88, ISA/IEC 62443, ISA-95, and ISA-101.
• Strong verbal and written communication skills for working with vendors, internal customers, employees, and contractors.

Nice to have

• Experience supervising personnel or coordinating group work activities.
• Experience in a highly regulated industry with strict documentation requirements.
• Exposure to CSV, MES, DCS, PCS, SCADA, PLC, LIMS, EBR, QMS, and plant data historians.
• Experience with Agile PLM, MS Project or Smartsheet, RAM CMMS, and TMS DCS.

Culture & Benefits

• Full-time daytime schedule with no stated end date.
• Approximately 25% travel required.
• Eligibility for bonus, stock, and benefits.
• Work in a fast-paced API-biopharmaceutical manufacturing environment focused on oligonucleotide-based therapeutics.