Validation Engineer I/II

JOB SUMMARY

The incumbent is responsible for assisting the Validation manager in completion of all project milestones. This includes installation, operational and performance qualification of equipment and utilities, environmental qualification, process validation, and preparation of all relevant documentation to meet regulatory requirements for new and existing products (includes standard operating procedures, technical reports and risk assessments). Duties require some knowledge in the pharma/biotech field.

JOB RESPONSIBILITIES

• Develop protocols, provides execution support, conduct some statistical data analysis, and report generation for various installation, operational and performance qualification activities under direct guidance.
• Ensure performance of all qualification activities is in accordance with internal procedures, cGMP industry and regulatory guidance.
• Investigates / troubleshoots validation problems.
• Support and/or initiates investigations into protocol non-conformances and site deviations.
• Serve as initiator and owner of validation related change controls and corrective preventative actions.
• Provides input to standard operating procedures related to validation practices.
• Support the implementation of validation programs (e.g., requalification).
• Depending upon experience level, may provide technical assistance to less experienced Validation engineers.

SPECIAL JOB REQUIREMENTS

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

KNOWLEDGE, SKILLS AND EXPERIENCE

EDUCATION / CERTIFICATIONS / LICENSES	Essential/Desired
Bachelor's Degree in Engineering	Essential
ON-THE-JOB EXPERIENCE
0-8 years of validation experience	Essential
SKILLS/ABILITIES
The ability to communicate with employees of all experience levels	Essential
The ability to report on project activity in a clear and concise manner	Essential
The ability to communicate with fellow project team members	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

 

Work Environment

• Regularly sit for long periods of time

Movement

• Frequently required to stand, sit, use hands to finger, handle or feed; 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
• 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.