Senior Process & Validation Engineer — GMP/CQV

Genezen; Indianapolis (IN); On-site; USD 90,000 - 140,000; Full time

Benefits offered by this job

Paid vacation days

401(k) plan with company match up to 6

Choice of healthcare plans

FSA and HSA programs

Employer-paid basic term life/personal

Voluntary disability, universal life/p

Job summary

Genezen, a growing gene therapy company in Fishers, Indiana, seeks a Sr. Process/Validation Engineer to support operations across MFG, FAC, QC, SC, MSAT and PD.

You will lead projects, evaluate equipment performance, develop procedures, and drive validation and calibration activities. The role requires 5+ years of engineering or PM experience, proficiency with AutoCAD, and the ability to coordinate cross-functional teams.

Qualifications

• BS/BA degree in Engineering, Science, Technical or related field.
• 5+ years of engineering/project management experience.
• Experience with CQV, master planning, CAPEX/OPEX, change control, and CI.

Responsibilities

• Prepare, schedule, coordinate and monitor their 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 business environment.
• Monitor compliance to all applicable FDA and EU practices, QA/QC policies, performance standards and specifications.
• Interact daily with internal team members and external third parties to interpret their needs and represent them in the field.
• Perform overall quality control of their work (budget, schedule, plans, personnel performance) and report regularly on project and maintenance/calibration status.

Skills

Project management

Leadership

QA/QC

Troubleshooting

Documentation

MS Office

Education

BS/BA in Engineering or Science

Tools

AutoCAD

Job description

Genezen, a growing gene therapy company in Fishers, Indiana, seeks a Sr. Process/Validation Engineer to support operations across MFG, FAC, QC, SC, MSAT and PD.

You will lead projects, evaluate equipment performance, develop procedures, and drive validation and calibration activities. The role requires 5+ years of engineering or PM experience, proficiency with AutoCAD, and the ability to coordinate cross-functional teams.