Sr. Process/Validation Engineer

Genezen•Indianapolis, IN

23h

About The Position

The Sr. Process/Validation Engineer plays a key role supporting operations at Genezen’s gene therapy facility and will provide operational support to all groups including MFG, FAC, QC, SC, MSAT and PD. The incumbent will provide a variety of support services including equipment performance evaluation, troubleshooting, procedure development, process and equipment monitoring, validation / qualification, CI’s and leadership of medium to large projects.

Requirements

BS/BA degree in Engineering, Science, Technical or related field
Pharmaceutical, Biomedical, or Medical Device experience
5+ years of engineering/project management experience
Proven working experience as an Engineer, Project Manager with experience in CQV, master planning. CAPEX/OPEX, change control, and continuous improvements/optimization
Adherence to all local, state, and governmental safety standards
Excellent knowledge of design and visualization software such as AutoCAD
Familiarity with rules, regulations, best practices, and performance standards
Advanced MS Office skills
Project management and supervision skills
Decision making ability and leadership skills
Time management and organization skills
Ability to work with multiple discipline projects
Criminal background check required

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 requirements 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.
Cooperate and communicate effectively with team members, other project participants, and upper management to assist with technical support.
Be seen as technical engineering expert and be responsible for daily operations team huddle and daily site standup meeting providing updates on equipment, qualification status, documentation, and any CAPA’s or deviations.
Troubleshoot equipment and systems issues and develop solutions.
Ensure internal and external team members/contractors maintain the highest quality standards.
Identifying deficiencies in MEP processes and developing improvements.
Developing, initiating, and managing all phases of projects, maintenance/calibration.
Preparing documentation of critical analysis and providing suggestions for correcting errors across projects and maintenance/calibration.