Sr. Process/Validation Engineer

JOB SUMMARY

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.   

ESSENTIAL JOB FUNCTIONS

•  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. 

 

SPECIAL WORK REQUIREMENTS

• Adaptability required as work schedule may change based on business needs
• Criminal background check required
• Other duties as assigned
  

KNOWLEDGE, SKILLS AND EXPERIENCE

EDUCATION/CERTIFCATIONS/LICENSES

BS/BA degree in Engineering, Science, Technical or related field	Essential
Pharmaceutical, Biomedical, or Medical Device experience	Essential

ON-THE-JOB EXPERIENCE

5+ years of engineering/project management experience	Essential
Proven working experience as an Engineer, Project Manager with experience in CQV, master planning. CAPEX/OPEX, change control, and continuous improvements/optimization	Essential
Adherence to all local, state, and governmental safety standards	Essential
Excellent knowledge of design and visualization software such as AutoCAD	Essential
Familiarity with rules, regulations, best practices, and performance standards	Essential

SKILLS/ABILITIES

Advanced MS Office skills	Essential
Project management and supervision skills	Essential
Decision making ability and leadership skills	Essential
Time management and organization skills	Essential
Ability to work with multiple discipline projects	Essential

Work Environment

• Frequently required to work in a BSL 2 environment with personal protective equipment/aseptic gowning
• Regularly required to work around large machinery and typical utilities seen in pharmaceutical facilities
• Occasionally exposed to moving mechanical parts; high, precarious places; toxic or caustic chemicals; hazardous waste; and risk of electrical shock
• Occasionally exposed to extremely loud noise levels
• Spending time on the floor during activity execution (maintenance, construction, commissioning, and qualification) is required

Movement

• Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms 
• Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl

Lifting

• Frequently lift and/or move up to 10 pounds
• Occasionally lift and/or move up to 25 pounds

Vision

• Frequently utilize close vision and the ability to adjust focus

Communication

• Frequently required to communicate by talking, hearing, using telephone and e-mail