Validation Engineer II/III

About the role

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

Genezen is hiring a Validation Engineer II/III to support validation and manufacturing operations by executing and documenting equipment, utility, facility, and process qualification activities. The role will assist in process transfers, scale-up, and process validation efforts while ensuring compliance with internal procedures, cGMPs and regulatory requirements.

Responsibilities include preparing validation protocols and reports, supporting the manufacture of cGMP materials, conducting risk assessments, and developing and maintaining quality system documentation, including SOPs, technical reports, and validation records. The position works cross-functionally to ensure projects are completed on schedule and in accordance with quality and regulatory expectations.

Job Responsibilities

• Protocol generation, execution support, data analysis, report generation and approval for various installation, operational and performance qualification activities
• Review and approve qualification documentation on behalf of the validation department.
• Ensure performance of all qualification activities is in accordance with internal procedures, industry best practices and regulatory guidance.
• Support investigations in protocol nonconformances, deviations discrepancies, and failures. Support root-cause investigations and development of appropriate CAPAs.
• Serve as initiator and owner of validation related change controls and corrective and preventative actions.
• Author standard operating procedures related to validation practices.
• Review engineering and technical documentation, including P&IDs, equipment specifications, drawings, manuals, and functional/design specifications.
• Support commissioning and startup activities and ensure appropriate transition from commissioning to qualification
• Support the execution and generation of formal risk assessments.
• Support the generation and implementation of validation programs.
• Identify opportunities to improve validation processes, reduce execution timelines, and increase operational efficiency while maintaining compliance.
• Support audits and regulatory inspections, as needed.

Special Work Requirements

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

Education/certifcations/licenses

• Bachelor's degree in Engineering, Biotechnology, Biological Sciences, or a related technical discipline.
• Essential

On-the-job Experience

• 5-8 years of validation experience
• Essential
• Experience working in clean room environments.
• Essential
• Experience with aseptic fill finish technique.

Essential

Experience with validation lifecycle management and continued process verification.

Essential

Knowledge, Skills and Experience

Strong interpersonal and communication skills, both verbal and written, with demonstrated experience preparing technical documents such as protocols, reports, SOPs, and risk assessments.

Essential

Ability to work collaboratively as part of cross-functional teams maintaining effective communication with project team members to achieve project objectives including effectively reporting project activity in a clear and concise manner.

Essential

Proficiency in Microsoft Office applications, including Excel, Word, PowerPoint, and Visio, with the ability to develop technical documentation, analyze data, and create process flow diagrams.

Essential

Demonstrated ability to effectively manage competing priorities, adapt to changing business needs, and meet challenging deadlines in a fast-paced environment while maintaining quality, compliance, and adherence to project timelines.

Essential

• Strong working knowledge of GxP regulations including 21 CFR Parts 11, 210/211, EU GMP Annex 1 and 11, data integrity guidances, ICH guidelines with the ability to assess compliance risks.
• Essential

Compensation Range

The anticipated annual salary range for the Validation Engineer II/III position is $105,000-$130,000. Actual annual salary and level will be determined based on relevant experience, skills and education.

Work Environment

• Regularly sit for long periods of time

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
• Rarely 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

Committed to Science

We are committed to scientific 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
• 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.