Principal Manufacturing Systems Engineer (Biotechnology)

Location: Holly Springs, North Carolina, United States; onsite manufacturing facility

Annual salary: $160,327–$216,913 USD

Company

hirify.global is a biotechnology company researching, manufacturing, and delivering medicines for serious illnesses across oncology, inflammation, general medicine, and rare disease.

What you will do

• Own delivery of a varied portfolio of information systems and automation projects, including planning, resource, risk, and financial management.
• Assess cross-system feasibility, define scope, prioritize initiatives, and recommend solutions for manufacturing operations.
• Translate strategic opportunities and emerging technologies into executable plans aligned with corporate standards and local business needs.
• Manage relationships with peers, IS service owners, business partners, enterprise IS teams, and vendors.
• Communicate project issues and solutions across multiple organizational levels.
• Elicit and analyze business needs and convert them into functional designs.

Requirements

• Doctorate with 2 years, master's degree with 4 years, bachelor's degree with 6 years, associate's degree with 10 years, or high school diploma/GED with 12 years of experience in information systems or manufacturing process automation.
• Manufacturing environment experience, preferably in the pharmaceutical or biotechnology industry.
• In-depth knowledge and hands-on coding experience with Emerson DeltaV, Rockwell FactoryTalk, Rockwell PLCs, and Aveva PI Data Historian.
• Experience with automation/process control systems, data historians, manufacturing execution systems, laboratory systems, or related IS platforms.
• Understanding of GAMP software development lifecycle, ANSI/ISA-S88 and S95 standards, 21 CFR Part 11, validation, and change control.
• Ability to lead and influence multifunctional teams, troubleshoot computerized systems, and apply cybersecurity and manufacturing network principles.

Nice to have

• Knowledge of the Kneat platform for commissioning and qualification documentation.
• Experience with Körber MES.
• Exposure to PAT, APC, AR/VR, location tracking, control towers, IIoT, and IDA technologies.

Culture & Benefits

• Collaborative, innovative, and science-based working environment.
• Health, dental, vision, life, disability, and flexible spending benefits.
• Retirement and savings plan with company contributions.
• Discretionary annual bonus and stock-based long-term incentives.
• Paid time-off plans and career development opportunities.
• Flexible work models may be available where applicable to the role.

Hiring process

• Applications are accepted until a candidate is selected or a sufficient number of applications is received.
• Sponsorship for the role is not guaranteed.