Validation Engineer II/III

Up Closets of North Cincinnati; Indianapolis (IN); On-site; USD 60,000 - 100,000; Full time

Job summary

Join an innovative and rapidly growing firm in the field of gene therapy, where your contributions will directly impact the development of new cures. This role involves assisting in validation processes, ensuring compliance with regulatory standards, and supporting a collaborative team environment. With a focus on scientific excellence and a commitment to patient care, you will be empowered to innovate and solve problems in a dynamic setting. If you're looking to make a meaningful difference in healthcare, this opportunity is perfect for you.

Benefits

Paid vacation days

401(k) plan with company match

Choice of several healthcare plans

FSA and HSA programs

Employer-paid basic term life insurance

Voluntary disability insurance

Qualifications

• 5-8 years of validation experience in a regulated environment.
• Strong understanding of cGMP regulations and technical writing skills.

Responsibilities

• Assist Validation Manager with project milestones and manufacturing support.
• Generate and approve qualification documentation for compliance.

Skills

Communication Skills

Technical Writing

Project Management

Problem Solving

Understanding of cGMP Regulations

Education

Bachelor’s Degree in Engineering

Tools

Microsoft Office

Excel

Visio

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 incumbent is responsible for assisting the Validation Manager in completion of all project milestones as well as manufacturing support. This includes performance qualification of equipment and utilities, environmental qualification, process transfer and scale-up, process validation, preparation of cGMP materials and preparation of all relevant documentation to meet regulatory requirements for new and existing products (includes standard operating procedures, technical reports and risk assessments).

ESSENTIAL JOB FUNCTIONS

• 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 local procedures, industry and regulatory guidance.
• Support investigations into protocol nonconformances and site deviations.
• Serve as initiator and owner of validation related change controls and corrective and preventative actions.
• Author standard operating procedures related to validation practices.
• Support the execution and generation of formal risk assessments.
• Support the generation and implementation of validation programs.
• Experience working in clean rooms.
• Experience with aseptic fill finish technique.

SPECIAL WORK REQUIREMENTS

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

EDUCATION/CERTIFICATIONS/LICENSES

A minimum of a Bachelor’s degree in Engineering.

ON-THE-JOB EXPERIENCE

5-8 years of validation experience.

KNOWLEDGE, SKILLS AND EXPERIENCE

• The ability to communicate with employees of all experience levels.
• The ability to report on project activity in a clear and concise manner.
• The ability to communicate with fellow project team members.
• Understanding of cGMP regulations.
• Technical writing ability.
• Familiarity with Microsoft Office, Excel, and Visio.
• Ability to work well with diverse groups in a matrix-style, growing, safety-focused organization.
• Ability to manage multiple activities with challenging timelines.
• Able to access crawl spaces and use ladders to access equipment.

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.

GENEZEN'S CURES VALUE-BASED COMPETENCIES

• 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 principles.
• 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, vested immediately.
• 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.