Assoc Director, Manufacturing Engineering Lead - Upstream (Biopharmaceutical Manufacturing)

Location: Research Triangle Park, North Carolina, United States; on campus

Salary: $147,000–$202,500 base salary per year

Company

hirify.global is a mid-sized biotechnology company developing life-changing medicines with the stability of an established business and a focus on inclusion, collaboration, learning, and excellence.

What you will do

• Lead and develop the Manufacturing Engineering function and a team of approximately 7–15 employees.
• Oversee the installation, validation, reliability, safety, compliance, and optimization of manufacturing process equipment and cGxP warehouse technologies.
• Set departmental goals, development plans, operating metrics, tactical priorities, resource plans, and capital forecasts.
• Represent Site Engineering and Facilities in manufacturing strategy, technical risk, and operational-direction decisions.
• Lead GMP validation strategy, execution, and lifecycle management in alignment with the Quality Management System and global procedures.
• Provide technical direction during critical equipment issues and drive equipment upgrades, continuous improvement, and engineering solutions supporting uninterrupted manufacturing.

Requirements

• Bachelor’s degree in engineering from an accredited college or university.
• At least 10 years of relevant experience in biotechnology, pharmaceutical, or an adjacent industry, including in-depth GMP validation, manufacturing, engineering, or facilities experience.
• At least 2 years managing or leading engineering professionals, contractors, or cross-functional technical teams.
• Knowledge of biopharmaceutical manufacturing operations, cGMP, GLP, EMEA, and ISO requirements.
• Experience working with FDA or comparable regulatory investigators, preparing responses to observations, and implementing corrective measures.
• Experience leading GMP validation activities and maintaining manufacturing systems in a compliant and validated state.
• Experience with large operating and capital budgets, complex engineering projects, and cross-site or cross-functional initiatives.
• Ability to support 24/7 manufacturing operations as business needs require and communicate effectively with Quality, EHS, Maintenance, Automation, manufacturing, and global engineering partners.

Nice to have

• Working knowledge of distributed control systems, programmable logic controllers, P&IDs, and standard operating procedures.
• Experience with manufacturing process equipment and supporting utility or facility systems.
• Lean Six Sigma, continuous-improvement, or operational-excellence experience.
• Contract management and contractor safety-management experience.
• Experience supporting large-scale, multi-use manufacturing facilities.
• Business acumen, strategic planning, capital-investment analysis, and resource-management capabilities.
• Ability to communicate engineering strategy and technical risk to senior leaders, regulators, vendors, and cross-functional partners.

Culture & Benefits

• Full-time regular employment with medical, dental, vision, life, disability, and wellness benefits.
• At least 15 days of paid vacation, year-end shutdown time, company holidays, personal-significance days, sick time, and paid maternity and parental leave.
• 401(k) with company matching, employee stock purchase plan, short- and long-term incentives, including cash bonus and equity opportunities.
• Tuition reimbursement of up to $10,000 per calendar year and participation in Employee Resource Groups.
• Inclusive workplace focused on belonging, collaboration, professional growth, and learning.