Validation Engineer II/III (CSV)

Lighthouse Sign Co.; Indianapolis (IN); On-site; USD 60,000 - 100,000; Full time

Job summary

An established industry player in gene therapy is seeking a dedicated Validation Specialist to assist in critical computer system validation projects. This role involves writing validation deliverables, developing test protocols, and ensuring compliance with regulatory standards. The ideal candidate will have a strong background in validation processes and GMP compliance, along with excellent communication skills. Join a dynamic team where your contributions will directly impact the development of innovative therapies and the success of the organization. This is an exciting opportunity to work in a fast-paced environment that values collaboration and problem-solving.

Benefits

Paid vacation days

401(k) plan with company match

Choice of healthcare plans

FSA and HSA programs

Employer-paid basic term life insurance

Voluntary disability insurance

Qualifications

• 3-7 years of validation experience with a bachelor's degree.
• Strong communication skills and ability to work independently.

Responsibilities

• Assist in completion of computer system validation project milestones.
• Develop test protocols and support qualification activities.
• Investigate validation problems and support corrective actions.

Skills

GMP compliance knowledge

Validation experience

Strong written and oral communication skills

Data Integrity Guidance

Ability to work independently

Education

Bachelor's degree in Engineering

Tools

Computerized systems

Building Management Systems

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 in completion of all computer system validation project milestones. This includes writing all validation deliverables within the Computer System Lifecycle, e.g. Validation Plans, Summary Reports, Configuration Specifications. Responsible for developing, revising test validation procedures/protocols, and preparation of all relevant documentation in accordance with appropriate regulatory agency validation requirements, uniQure quality management system and current industry practices (includes standard operating procedures, technical reports and risk assessments).

ESSENTIAL JOB FUNCTIONS

1. Develop moderately complex test protocols, provides on-site execution support, data analysis, and report generation for various installation, operational and performance qualification activities.
2. Ensure performance of all qualification activities is in accordance with internal procedures, cGMP industry and regulatory guidance.
3. Investigates / troubleshoots validation problems.
4. Support and/or initiate investigations into protocol non-conformances and site deviations.
5. Serve as initiator and owner of validation related change controls and corrective and preventative actions.
6. Provides input to standard operating procedures related to validation practices.
7. Support the implementation of validation programs (e.g., requalification).
8. Represent the validation department at team meetings or projects.
9. Performs periodic reviews and ongoing support of validated systems post Go-Live.
10. Perform revalidation and change control validation related activities.
11. Ability to apply complex system validation principles to work assignments.
12. Responsible for executing and reviewing control systems validation activities including projects associated with BMS, CMS, and other automation upgrades.
13. Assess the impact of system changes thru change management and change control systems; participate in the planning and implementation of change.
14. Assist validation activities of cross functional teams that include technical functions such as Quality Control, Information Systems, Manufacturing and QA Engineering.

SPECIAL WORK REQUIREMENTS

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

EDUCATION/CERTIFICATIONS/LICENSES

A minimum of a Bachelor's degree in Engineering is required.

ON-THE-JOB EXPERIENCE

3-7 years of validation experience with a bachelor's degree; 2-5 years of validation experience with a master's degree.

KNOWLEDGE, SKILLS AND EXPERIENCE

The individual must possess strong written and oral communication skills: The ability to communicate with employees of all experience levels from uniQure and other contract firms. The ability to report on project activity in a clear and concise manner. The ability to negotiate when necessary and compromise with other project team representatives to achieve project goals. The ability to listen and respect fellow project team member’s ideas and opinions and work through conflict and disagreements. GMP compliance knowledge including knowledge of 21 CFR Parts 11, 210, 211, and 820 requirements, Data Integrity Guidance, ICH Q7A requirements, and GAMP 5. Experience in thorough testing of applications, computerized systems, changes and implementations. Excellent written and oral communication to include accurate and legible documentation skills. Ability to work independently in a fast-paced environment with a strong work ethic. Must be able to sit or stand for prolonged periods of time. Good knowledge and skills in engineering of Automation for HVAC/ Process Utility/Monitoring Building Management Systems.

Movement

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

Lifting

1. Frequently lift and/or move up to 10 pounds.
2. Rarely lift and/or move up to 25 pounds.

Vision

1. Frequently utilize close vision and the ability to adjust focus.

Communication

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

GENEZEN'S CURES VALUE-BASED COMPETENCIES

Committed to Science
Urgency in action for the patients
Resilience & Grit in operations
Execute with Excellence & Integrity
Solutions driven for our partners

GENEZEN'S BENEFITS

1. Paid vacation days, amount based on tenure.
2. 401(k) plan with company match up to 6% of salary, vested immediately.
3. Choice of several healthcare plans.
4. FSA and HSA programs.
5. Employer-paid basic term life/personal accident insurance.
6. Voluntary disability, universal life/personal accident insurance.

ADDITIONAL DETAILS

1. 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.
2. This position requires a criminal background check.
3. Genezen is an Equal Opportunity Employer.
4. Genezen participates in EVerify.
5. Genezen is interested in every qualified candidate who is eligible to work in the United States; however, we are not able to sponsor visas.