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Validation Engineer I/II (CSV)

Lexington, MA

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

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

SPECIAL WORK REQUIREMENTS

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

EDUCATION/CERTIFCATIONS/LICENSES

 

A minimum of a Bachelors degree in Engineering

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

Desired

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.

Essential

The ability to report on project activity in a clear and concise manner.

Essential

The ability to negotiate when necessary and compromise with other project team representatives to achieve project goals.

Essential

The ability to listen and respect fellow project team member’s ideas and opinions and work through conflict and disagreements.

Essential

GMP compliance knowledge including knowledge of 21 CFR Parts 11, 210, 211, and 820 requirements, Data Integrity Guidance, ICH Q7A requirements, and GAMP 5.

Essential

Experience in thorough testing of applications, computerized systems, changes and implementations

Essential

Excellent written and oral communication to include accurate and legible documentation skills.

Essential

Ability to work independently in a fast-paced environment with a strong work ethic.

Essential

Must be able to sit or stand for prolonged periods of time.

Essential

Good knowledge and skills in engineering of Automation for HVAC/ Process Utility/Monitoring Building Management Systems.

Essential

 

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

 

 

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 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, vested immediately
  • 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.

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This position requires a criminal background check and drug screening.

Genezen is an Equal Opportunity Employer.

Genezen is interested in every qualified candidate who is eligible to work in the United States; however, we are not able to sponsor visas.

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