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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Insight Global's Workforce Privacy Policy:

https://insightglobal.com/workforce-privacy-policy/.

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)

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