Sr. Process/Validation Engineer

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

The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures.

WORKING AT GENEZEN

Manypeople have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work. Every employee contributes to the success of the company and you can be part of that team.

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

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

SKILLS/ABILITIES

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

• 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

GENEZEN'S CURES VALUE-BASED COMPETENCIES

Committed to Science
We are committed toscientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare.

Urgency in action for the patients
We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs.

Resilience & Grit in operations
We are committed to overcoming challenges, learning from failures, and persistently striving for success.

Execute with Excellence & Integrity
We are dedicated to delivering quality results and upholding ethical principals.

Solutions driven for our partners
We are committed to being a proactive, collaborative, creative and open-minded partner.

GENEZEN'S BENEFITS

• Paid vacation days, amount based on tenure
• 401(k) plan with company match up to 6% of salary
• Choice of several healthcare plans
• FSA and HSA programs
• Employer-paid basic term life/personal accident insurance
• Voluntary disability, universal life/personal accident insurance

ADDITIONAL DETAILS

• Nothing in the job description for this role restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
• This position requires a criminal background check.
• Genezen is an Equal Opportunity Employer.
• Genezen participates in EVerify.
• Genezen is interested in every qualified candidate who is eligible to work in the United States; however, we are not able to sponsor visas.

Genezen has operates two locations: one in Fishers, Indiana and the second in Lexington, Massachusetts.