Senior Process & CQV Engineer - Gene Therapy Ops

Genezen; Fishers (IN); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Paid vacation days

401(k) plan with company match

Medical, dental & vision plans

Life insurance

Job summary

Genezen is seeking a Senior Process/Validation Engineer to support operations at our gene therapy facility. You will provide operational support across MFG, FAC, QC, SC, MSAT and PD, leading projects from initiation through calibration and validation.

Responsibilities include evaluating equipment performance, troubleshooting, developing procedures, monitoring processes, and leading medium to large projects with cross-functional teams in a fast-growing company.

Qualifications

• BS/BA in Engineering, Science, Technical or related field required.
• 5+ years of engineering/project management experience required.
• Experience with CQV, master planning, CAPEX/OPEX, change control, and continuous improvements/optimization is essential.
• Adherence to safety standards and familiar with rules and performance standards.

Responsibilities

• Prepare, schedule, coordinate and monitor engineering projects.
• Manage projects related to workflow optimization and continuous improvement.
• Support change management processes to achieve business outcomes.
• Interact with internal teams and external parties to interpret needs and represent them in the field.
• Lead daily operations huddles and provide updates on equipment and validation status.

Skills

MS Office

Project management

Leadership

Time management

Cross-discipline teamwork

Decision making

Education

BS/BA in Engineering, Science, Tech or related field

Tools

AutoCAD

Job description

Genezen is seeking a Senior Process/Validation Engineer to support operations at our gene therapy facility. You will provide operational support across MFG, FAC, QC, SC, MSAT and PD, leading projects from initiation through calibration and validation.

Responsibilities include evaluating equipment performance, troubleshooting, developing procedures, monitoring processes, and leading medium to large projects with cross-functional teams in a fast-growing company.