Validation Specialist

6 days ago

Lexington, Kentucky, United States Genezen Full time

Job Summary

The Validation Engineer will assist the Validation Manager in completing all project milestones and 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.

Key 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 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

Requirements

  • A minimum of a Bachelor's degree in Engineering
  • 5-8 years of validation 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

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

We are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare.

We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs.

We are committed to overcoming challenges, learning from failures, and persistently striving for success.

We are dedicated to delivering quality results and upholding ethical principles.

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

9 observed holidays + 1 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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