Process Engineer – Biologics

Intellectt INC

  • Wilson, NC
  • 3 days ago

    Highlights

    GMP Biologics Manufacturing, Large Molecule Drug Substance (LMDS), Process Engineering, Greenfield/Brownfield Facility Startup, Process Systems Design, CAPEX Projects, Technology Transfer, Process-Fit-to-Plant, Equipment Installation, Commissioning & Qualification (CQV). This role combines process, equipment, utility, and facility engineering expertise to support technology transfer, capital projects, and successful manufacturing startup.

    Numbers & Facts

    LocationWilson, NC

    Description

    Job Title: Process Engineer Biologics
    Company: Intellectt Inc.
    Location: Wilson, NC
    Employment Type: W2 Contract
    Pay Rate: $45-50/hour
    Work Arrangement: Onsite

    Job Summary

    We are seeking an experienced Process Engineer to support a large-scale Large Molecule Drug Substance (LMDS) manufacturing project in Wilson, NC. The engineer will support process design, installation, startup, commissioning, qualification, and operational readiness for GMP biologics manufacturing systems and equipment.

    This role combines process, equipment, utility, and facility engineering expertise to support technology transfer, capital projects, and successful manufacturing startup.

    Key Responsibilities
    • Support process systems from engineering design and installation through startup, commissioning, qualification, and operational handover.
    • Serve as a process systems owner and subject matter expert for GMP biologics manufacturing equipment and systems.
    • Troubleshoot equipment and process issues and recommend design modifications to meet manufacturing needs.
    • Support capital expenditure (CAPEX) projects, process improvements, and manufacturing readiness activities.
    • Provide technical leadership for technology transfer, new technology implementation, and process-fit-to-plant assessments.
    • Translate business, manufacturing, and technical requirements into practical engineering solutions.
    • Coordinate with Manufacturing Technical Operations, Engineering, Quality, Manufacturing, Automation, Validation, Utilities, and Facilities teams.
    • Work with architecture and engineering (A&E) firms, construction partners, and equipment vendors to resolve technical issues and support project delivery.
    • Ensure engineering activities meet GMP, safety, regulatory, quality, and project requirements.
    • Manage competing priorities and technical risks across multiple complex projects.
    Required Qualifications
    • Bachelor's degree in Chemical, Mechanical, Biochemical Engineering, or a related engineering discipline.
    • 8+ years of process or plant engineering experience within GMP large molecule biologics manufacturing facilities.
    • Experience supporting greenfield or brownfield GMP facility startup, including coordination across process systems, automation, utilities, facilities, and operations.
    • Strong knowledge of biologics drug substance manufacturing and GMP process systems.
    • Experience supporting CAPEX projects and process improvements, with the ability to manage multiple complex assignments.
    • Strong analytical, troubleshooting, communication, leadership, collaboration, conflict management, and risk management skills.
    • Ability to work onsite full-time in Wilson, NC.
    • Legal authorization to work in the United States.
    Preferred Qualifications
    • Experience with technology transfer and process-fit-to-plant activities.
    • Advanced degree such as an MS, MBA, or Ph.D.
    • Professional Engineer (PE) license, FPX certification, or experience applying Lean or Six Sigma methodologies.
    • Experience coordinating equipment vendors, A&E firms, and construction teams within GMP manufacturing environments.
    • Ability to support limited domestic or international travel as needed.

    Key Skills:

    GMP Biologics Manufacturing, Large Molecule Drug Substance (LMDS), Process Engineering, Greenfield/Brownfield Facility Startup, Process Systems Design, CAPEX Projects, Technology Transfer, Process-Fit-to-Plant, Equipment Installation, Commissioning & Qualification (CQV).

    Recruiter Contact:

    Rudra Prasad Kunnath
    Email:

    prasad.kunnath@intellectt.com


    Phone: 732-200-2726 EXT 189

    Benefits: Employees hired into this position are eligible for benefits subject to applicable plan terms and eligibility requirements.

    • Health Insurance: Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for the full cost of insurance premiums.
    • Retirement: A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided.
    • Paid Time Off: No PTO is provided beyond what is required by applicable state and local laws.

    Equal Employment Opportunity:

    Intellectt Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local law.

    Similar Jobs