Principal Process Engineer

Job Description Day to day: We are seeking experienced Principal Process Engineers to support a large-scale, greenfield biologics manufacturing project in the Raleigh-Durham surrounding area. These roles will function as process system owners, driving the design, implementation, and startup of critical manufacturing systems. This is a highly technical, hands-on role focused on engineering ownership across the full lifecycle — from design and requirements definition through startup and operational support — rather than traditional CQV execution. Key Responsibilities

•  Serve as process system owner / SME for assigned manufacturing areas
•  Partner with A&E firms, EPCM teams, and equipment vendors to support design, build, and implementation
•  Lead process design, requirements definition (URS/FRS), and technical decision-making
•  Support equipment selection, system integration, and commissioning/startup activities
•  Provide hands-on troubleshooting and technical support during startup and early operations
•  Drive technology transfer and process fit-to-plant alignment
•  Collaborate cross-functionally with Manufacturing, Quality, Engineering, and Automation
•  Lead or support risk assessments, deviation investigations, and continuous improvement efforts
•  Ensure alignment with GMP and regulatory requirements
•  Contribute to "right first time" startup execution across capital projects What Success Looks Like
•  Engineers who can step in and own systems end-to-end, not just execute validation
•  Ability to reduce team bandwidth constraints by driving specialization
•  Strong contributors to design, build, and startup phases of the program Leadership & Collaboration
•  Ability to operate as a technical lead across multiple stakeholders
•  Strong communication and cross-functional collaboration skills
•  Experience working with external partners (EPCM, vendors, integrators)
•  Capable of owning systems end-to-end and driving accountability We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day.

We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.

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Skills and Requirements Preferred:

•  Advanced degree (MS/MBA/PhD)
•  Lean / Six Sigma experience

Must Haves:

•  5+ years of experience in process engineering within GMP environment (not CQV focused) o Proven ability to troubleshoot complex process systems o Develop design concepts into technical requirements
•  Experience in greenfield or large-scale brownfield GMP facilities strongly preferred or at least experience supporting large scale capital projects / construction driven environments
•  Demonstrated success supporting startup and/or capital project execution
•  Bachelor's degree in engineering Discipline
•  Experience with DeltaV
•  Deep experience in Downstream Processing / equipment (DSP) high priority (Mix of the following): o Chromatography systems (AKTA / columns / skids) o Ultrafiltration / diafiltration systems (UF / DF skids) o Filtration systems (depth filtration, microfiltration, or sterile filtration) o Centrifuges o Stainless Steel or single use tanks (product hold / buffer hold) o Lyophilizers o Capping / inspection / packaging systems o CIP (clean in place systems) o SIP (steam in place systems) o Formulation systems / mixing vessels o Media / buffer prep systems o washers and autoclaves (open to varying experience levels)