Automation Engineer, GMP

Location: Fully onsite in Pennington, New Jersey, United States

Salary: $90,000–$120,000 annually

Company

hirify.global is a biotechnology company providing research, development, and biopharmaceutical production services, including cell and gene therapy, vaccine, antibody, and protein development.

What you will do

• Administer and manage site automation systems, including SCADA, PLCs, notification systems, and computerized QC laboratory instruments.
• Install, maintain, back up, validate, upgrade, and retire automation systems while following change control procedures.
• Develop validation protocols, reports, lifecycle documents, change controls, and test scripts, and collect test evidence.
• Monitor system integrity, availability, performance, and operability; investigate technical issues and perform root cause analysis for production errors.
• Manage user access and coordinate automation-related changes with IT, Quality Assurance, Manufacturing, Facilities and Engineering, business teams, and vendors.
• Recommend and integrate bioprocess equipment and Process Analytical Technologies, including systems used with bioreactors, chromatography, ultrafiltration, and QC instruments.

Requirements

• Bachelor’s degree in Electrical Engineering, Computer Science, IT, Engineering, or a related field, plus 5–7 years of relevant experience.
• Proven experience as an IT Automation Engineer or in a similar role, with direct knowledge of biologics process equipment, SCADA/control systems, and IT networking infrastructure.
• Experience with equipment qualification, computer system validation, SCADA architecture, and biotech process equipment or systems.
• Knowledge of FDA, ICH, USP, and EMEA guidance, including 21 CFR Part 11, EU EudraLex Annex 11, and GAMP 5.
• Ability to analyze and resolve technical problems, manage competing priorities, and collaborate across functional teams.
• Expertise with industrial automation and IT systems is required; experience with Rockwell Automation, Wonderware Archestra, TopView, Vaisala ViewLinc, Unicorn, DeltaV, SAP, Maximo, BAS, and Veeva Vault is advantageous.

Culture & Benefits

• Medical, dental, and vision insurance.
• 401(k) retirement plan with a company match that vests fully on day one.
• Paid parental leave after three months of employment.
• Paid vacation, personal, sick, floating holiday, and company holiday leave.
• Flexible spending and health savings accounts, life and disability insurance, legal assistance, commuter benefits, and well-being programs.