Validation Engineer

6 Months ago • 4 Years + • Quality Assurance

Job Summary

Job Description

Develop, support, and implement basic validation initiatives aligned with site goals. Coordinate and document validation efforts across departments. Create and execute validation protocols for equipment, materials, cleaning, and processes, including statistical analysis of data and compiling documentation. Assist with validation projects with minimal supervision, ensuring deliverables and timelines are met. Ensure validation documentation is generated, reviewed, and approved per site and global procedures. Review and approve change controls for laboratory and production systems, assessing system changes and qualification needs. Support change requests, CAPA, investigations, non-conformances, and waivers as part of the QA function. Maintain validated states through periodic reviews of equipment and processes. Revise and update validation SOPs and the Site Validation Master Plan. Ensure timely completion of requalification and periodic review schedules. Continuously improve and update the validation program. Participate in QA oversight for production, IND, MES, calibration, maintenance, and facilities.
Must have:
  • Bachelor’s Degree in Engineering or Life Science
  • Minimum 4 years of Validation experience
  • Knowledge of ISO 13485
  • Knowledge of FDA validation requirements
  • Understanding of FDA 21 CFR Part 820
  • Understanding of cGMPs
  • Understanding of validation/qualification concepts
  • Ability to identify critical functions of equipment/systems
  • Ability to work independently
  • Time management skills for simultaneous projects
  • Risk assessment team participation
  • Ability to learn new validation methodologies
  • Effective technical writing skills
  • Effective oral communication skills
Good to have:
  • High School Diploma/GED with 8 years of Validation experience (in lieu of degree)

Job Details

Description

Position Summary & Responsibilities:

Develop, support and implement basic validation initiatives as defined in site goals and objectives. Responsible for the coordination and documentation of validation efforts with other departments. Develop and execute equipment, material, cleaning and process validation protocols including statistical analysis of data generated by validation studies.

  • Write and execute protocols and test cases for validation. Develop and execute equipment, material, cleaning, and process validation protocols including statistical analysis of data generated from validation studies and compiling relevant documentation. Assist on the execution of validation projects with minimal oversight (deliverables, timelines, materials, etc.) to support site initiatives.
  • Assure validation documentation is generated, reviewed and approved in accordance to site and global procedures.
  • Review and approve change controls for laboratory and production systems. Support change control processes through assessment of system changes and identifying the extent of qualification or requalification activities as needed. Support Change Requests, CAPA, investigations, Non-Conformances, and Waivers as QA function.
  • Ensure validated state is maintained by performing periodic review of equipment, processes, etc.
  • Revise and update validation SOPs and Site Validation Master Plan as required.
  • Ensure all items on the requalification and periodic review schedule are performed on time.
  • Continuously improve and update the validation program.
  • Participate in QA oversight activities for production, IND, MES, calibration, maintenance, and facilities.
  • Reasonable, reliable attendance and punctuality is an essential job function required for this position.

 Education, Skills, & Experience:

  • Bachelor’s Degree in Engineering or Life Science and a minimum of four (4) years of Validation experience in a related industry. 
    • In lieu of a degree, a High School Diploma/GED with 8 years of Validation experience is also accepted
  • Requires basic knowledge of ISO 13485 and FDA validation requirements including knowledge of FDA 21 CFR Part 820. Also requires understanding of cGMPs and validation / qualification concepts.
  • Must be able to identify and understand critical functions and features of equipment and systems.
  • Must be able to work independently, manage time to work on several simultaneous projects, participate on risk assessment teams, and learn/apply new validation methodologies.
  • Requires effective technical writing and oral communication skills to interact across all levels of the organization.

#LI-US #biojobs

Please be aware that recruitment related scams are on the rise. Fraudulent job postings are being placed on other websites, and individuals posing as bioMérieux Talent Acquisition team members are reaching out via email or text message in an attempt to collect your personal and confidential information. In some cases, these scammers are also conducting bogus interviews prior to extending fraudulent offers of employment. Beware of individuals reaching out using general phone numbers and non-bioMerieux email domains (i.e. Hotmail.com, Gmail.com, Yahoo.com, etc.). If you are concerned that an interview experience or offer of employment might be a scam, please make sure you are searching for the posting on our careers site https://careers.biomerieux.com/ or contact us at recruitment@biomerieux.com.

BioMérieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant’s identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMérieux’s or its affiliates’ application process by contacting us via telephone at (385) 770-1132, by email at recruitment@biomerieux.com, or by dialing 711 for access to Telecommunications Relay Services (TRS).

Similar Jobs

Playtech - Software Engineer

Playtech

Bremen, Bremen, Germany (On-Site)
5 Months ago
Enphase Energy - Sr Staff Data Analyst - Quality

Enphase Energy

Bengaluru, Karnataka, India (On-Site)
11 Months ago
Varonis  - Alliance Marketing Manager

Varonis

United States (Remote)
2 Months ago
Unity - Senior BI Developer, Fraud Operations

Unity

San Francisco, California, United States (On-Site)
2 Months ago
Snyk - Executive Assistant

Snyk

Boston, Massachusetts, United States (On-Site)
4 Weeks ago
Mighty Jaxx - Software Quality Assurance Intern

Mighty Jaxx

Singapore (On-Site)
4 Weeks ago
Riot Games - QA Engineer III - 2XKO

Riot Games

Los Angeles, California, United States (On-Site)
3 Months ago
Ion - Quality Assurance Engineer

Ion

Milan, Lombardy, Italy (On-Site)
3 Months ago
Qualcomm - Senior Lead QA Engineer

Qualcomm

Hyderabad, Telangana, India (On-Site)
1 Month ago
NVIDIA - Senior Hardware Validation Engineer

NVIDIA

Canada (On-Site)
4 Months ago

Get notifed when new similar jobs are uploaded

Similar Skill Jobs

The Walt Disney Company - Newswriter/Producer

The Walt Disney Company

San Francisco, California, United States (On-Site)
4 Months ago
Blinkhealth - Pharmacy Partner Coordinator

Blinkhealth

Pittsburgh, Pennsylvania, United States (On-Site)
1 Month ago
Forescout Technologies  Inc  - Senior QA Engineer

Forescout Technologies Inc

Plano, Texas, United States (Hybrid)
1 Month ago
beghou consulting - Consultant- CE

beghou consulting

Pune, Maharashtra, India (Hybrid)
4 Months ago
Epic Games - Senior DevOps Engineer

Epic Games

(On-Site)
3 Months ago
GHX - Manager Software Development

GHX

Hyderabad, Telangana, India (On-Site)
3 Months ago
Moloco - Senior New Business Manager

Moloco

Seoul, South Korea (On-Site)
4 Weeks ago
Token Metrics - Crypto QA Automation Engineer

Token Metrics

Athens, Greece (Remote)
1 Year ago
Low Pixel Studios - QA Tester (Remote)

Low Pixel Studios

(Remote)
7 Months ago
Western Digital - Engineer, Failure Analysis Engineering

Western Digital

Prachin Buri, Thailand (On-Site)
3 Months ago

Get notifed when new similar jobs are uploaded

Jobs in Hazelwood, Missouri, United States

Hawkeye Innovations - Systems Technician

Hawkeye Innovations

Rosemont, Illinois, United States (On-Site)
4 Months ago
Illumina - Senior Staff Supplier Relationship

Illumina

San Diego, California, United States (On-Site)
1 Year ago
Workato - VP, Product and Engineering

Workato

San Francisco, California, United States (On-Site)
1 Month ago
Adyen - Head of Project Operations Management, Americas

Adyen

Chicago, Illinois, United States (On-Site)
4 Weeks ago
The Walt Disney Company - Senior Gameplay Engineer

The Walt Disney Company

Glendale, California, United States (Remote)
1 Month ago
Apple - US-Store Leader

Apple

Houston, Texas, United States (On-Site)
2 Months ago
quience - Sr. Paid Social Ad Operations Specialist

quience

United States (Remote)
3 Months ago
Activision - Lead Systems Designer

Activision

Middleton, Wisconsin, United States (Hybrid)
1 Month ago
Thumbtack - Senior Engineering Manager, Data

Thumbtack

United States (Remote)
4 Weeks ago
Glean - Sales Development Manager

Glean

Nashville, Tennessee, United States (On-Site)
2 Months ago

Get notifed when new similar jobs are uploaded

Quality Assurance Jobs

Adyen - Engineering Manager - Test Enablement

Adyen

Amsterdam, North Holland, Netherlands (On-Site)
4 Weeks ago
Amber - Localization Quality Assurance (Italian)

Amber

Quebec, Canada (Hybrid)
4 Months ago
Playtika - QA Automation Engineer

Playtika

Poland (Hybrid)
5 Months ago
SoftSwiss - QA Engineer - Senior

SoftSwiss

Warsaw, Masovian Voivodeship, Poland (Remote)
1 Month ago
Paytm - Senior QA Engineer

Paytm

Noida, Uttar Pradesh, India (On-Site)
1 Month ago
Fandom  - Quality Engineer Intern

Fandom

Poznań, Greater Poland Voivodeship, Poland (On-Site)
3 Weeks ago
New Globe - Quality Assurance Engineer

New Globe

Lagos, Lagos, Nigeria (On-Site)
4 Weeks ago
reality.co - Senior QA Specialist

reality.co

Kraków, Lesser Poland Voivodeship, Poland (On-Site)
1 Month ago
Nagarro - Senior Staff Engineer, QA Automation

Nagarro

Portugal (Remote)
9 Months ago
HCL Tech - Senior Test Manager

HCL Tech

Arkansas, United States (On-Site)
2 Months ago

Get notifed when new similar jobs are uploaded

About The Company

Burlington, North Carolina, United States (On-Site)

Hazelwood, Missouri, United States (On-Site)

Hazelwood, Missouri, United States (On-Site)

Hazelwood, Missouri, United States (On-Site)

Salt Lake City, Utah, United States (On-Site)

Hazelwood, Missouri, United States (On-Site)

Salt Lake City, Utah, United States (On-Site)

Hazelwood, Missouri, United States (On-Site)

Durham, North Carolina, United States (On-Site)

View All Jobs

Get notified when new jobs are added by BioFire

Level Up Your Career in Game Development!

Transform Your Passion into Profession with Our Comprehensive Courses for Aspiring Game Developers.

Job Common Plug