Staff Engineer, Process Systems (Biotechnology)

Location: North Carolina; remote work arrangement

Salary: $157,000–$183,000 per year, plus comprehensive benefits and equity

Company

hirify.global supports biologics manufacturing facilities and the commercial launch and routine GMP manufacturing of biopharmaceutical products.

What you will do

• Lead engineering activities for utilities, process equipment, automation systems, facilities, and other advanced biotechnological systems.
• Direct validation initiatives and oversee protocols, plans, reports, and validation data analysis.
• Lead FAT, SAT, IQ/OQ/PQ, inspections, risk assessments, feasibility studies, and conceptual and basic design activities.
• Manage complex cross-functional engineering projects from conception through completion, including scope, timelines, budgets, resources, and quality standards.
• Coordinate engineering activities with Process Development, MSAT, Supply Chain, Quality, Regulatory, Project Management, contractors, suppliers, and CDMOs.
• Lead the transition from capital project implementation to ongoing engineering support, preventive maintenance, upgrades, and continuous improvement.

Requirements

• Bachelor’s or Master’s degree in Engineering, Biotechnology, or a related field, with 10+ years of bioprocessing or process engineering experience in biotechnology, pharmaceutical, or biopharmaceutical manufacturing.
• Leadership experience managing engineering teams and large-scale CapEx projects involving utilities, process equipment, and automation systems.
• Extensive knowledge of biopharmaceutical manufacturing, including DCS, ISA-88 batch process control, PLC-based control systems, upstream and downstream processing, aseptic processing, and sterilization.
• Expert knowledge of cGMP, FDA, EMA, ICH, and other global regulatory requirements, plus experience supporting inspections, audits, and customer site visits.
• Advanced proficiency in statistical analysis, risk assessment, process validation, quality management systems, and electronic documentation systems.
• Strong leadership, communication, problem-solving, decision-making, mentoring, and multi-project management skills.

Culture & Benefits

• Remote work arrangement, subject to business needs, job responsibilities, and company policy.
• Cross-functional collaboration with internal teams, senior leadership, contractors, suppliers, and CDMO partners.
• Comprehensive benefits package.
• Equity component included in the compensation package.
• Opportunity to mentor engineers and drive innovation, standardization, and continuous improvement.