Sr. Process/Validation Engineer

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

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

Many people 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

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

GENEZEN'S CURES VALUE-BASED COMPETENCIES

C

ommitted to Science

U

rgency in action for the patients

R

esilience & Grit in operations

E

xecute with Excellence & Integrity

S

olutions driven for our partners

GENEZEN'S BENEFITS

• Paid vacation days, amount based on tenure
• Paid sick time
• 10 observed holidays + 2 floating holiday + 1 volunteer day
• 401(k) plan with company match up to 6% of salary
• Share Appreciation Rights
• Choice of several healthcare plans
• FSA and HSA programs
• Dental & vision care
• Employer-paid basic term life/personal accident insurance
• Voluntary disability, universal life/personal accident insurance
• Accidental Death & Dismemberment (AD&D) 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.

Fishers is a suburb of Indianapolis. Fishers was named the #1 place to live in the US by Money Magazine in 2017 for its livability, safety and entrepreneurship. Fishers is one of the fastest growing communities in Indiana and is dedicated to supporting a high quality of life for all its residents. Nearby Indianapolis is home to professional and college sports teams, the Indy 500, a growing art community and the world’s largest children’s museum--to name just a few reasons why this area is a great place to live.

Lexington, Massachusetts, located just northwest of Boston, is renowned as a historic suburb with a rich cultural heritage. It boasts picturesque New England charm, tree-lined streets, and a vibrant community. Known for its pivotal role in the American Revolution, Lexington offers visitors and residents alike a blend of historical landmarks, modern amenities, and a strong sense of community pride.