Senior Process & Validation Engineer, Gene Therapy Ops

Genezen; Fishers (IN); On-site; USD 110,000 - 165,000; Full time

Benefits offered by this job

Paid vacation days

401(k) with company match up to 6%

Healthcare plans

FSA and HSA programs

Life/personal accident insurance

Voluntary disability

Job summary

Genezen, a gene therapy-focused company, seeks a Sr. Process / Validation Engineer to support operations across MFG, QC, MSAT, and PD. The role involves equipment evaluation, troubleshooting, procedure development, process monitoring, and leading medium-to-large projects.

Ideal candidates have 5+ years of engineering/project management experience, with CQV and CAPEX/OPEX knowledge, and a strong emphasis on safety and regulatory compliance.

Qualifications

• BS/BA degree in Engineering, Science, Technical or related field (Essential)
• Pharmaceutical, Biomedical, or Medical Device experience (Essential)
• 5+ years of engineering/project management experience
• Proven working experience as an Engineer, Project Manager with CQV, master planning, CAPEX/OPEX, change control, and continuous improvements/optimization
• Adherence to all local, state, and governmental safety standards
• Excellent knowledge of AutoCAD and design/visualization software

Responsibilities

• Prepare, schedule, coordinate and monitor assigned engineering projects.
• Manage projects associated with workflow optimization, mistake-proofing, and continuous improvement.
• Supports change management processes to achieve desired business outcomes in a complex environment.
• Monitor compliance to FDA and EU practices, QA/QC policies, and performance standards.
• Interact with internal teams and external parties to interpret needs and represent them in the field.
• Lead daily operations huddle and site standup with updates on equipment, qualification status, and CAPAs or deviations.

Job description

Genezen, a gene therapy-focused company, seeks a Sr. Process / Validation Engineer to support operations across MFG, QC, MSAT, and PD. The role involves equipment evaluation, troubleshooting, procedure development, process monitoring, and leading medium-to-large projects.

Ideal candidates have 5+ years of engineering/project management experience, with CQV and CAPEX/OPEX knowledge, and a strong emphasis on safety and regulatory compliance.