Validation Engineer

6 Months ago • 4 Years + • Quality Assurance

Job Summary

Job Description

The Validation Engineer will develop, support, and implement validation initiatives, coordinating with other departments and documenting validation efforts. Responsibilities include writing and executing protocols and test cases for equipment, material, cleaning, and process validation. This involves statistical analysis of data and compiling documentation. The role also entails reviewing and approving change controls, supporting change control processes, and ensuring validated states are maintained. Furthermore, the engineer will revise validation SOPs, update the Site Validation Master Plan, and participate in QA oversight activities. This role requires a strong understanding of validation principles and regulations, including ISO 13485, FDA 21 CFR Part 820, and cGMPs. The engineer must be able to work independently, manage time, and apply new validation methodologies. Effective technical writing and communication skills are also essential.
Must have:
  • Write and execute validation protocols and test cases.
  • Perform statistical analysis of validation data.
  • Review and approve change controls for systems.
  • Ensure validated state is maintained.
  • Bachelor's degree in Engineering or Life Science.

Job Details

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

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

bytedance - Student Researcher (Doubao (Seed) - Foundation Model - Vision and Language) - 2025 Start (PhD)

bytedance

Seattle, Washington, United States (On-Site)
9 Months ago
The Globel Talent Co - Virtual Assistant (German-speaker)

The Globel Talent Co

Romania (Remote)
6 Months ago
P99 soft - Sr Network Engineer

P99 soft

Bengaluru, Karnataka, India (On-Site)
3 Months ago
PhonePe - System Engineer

PhonePe

Bengaluru, Karnataka, India (On-Site)
1 Month ago
HoYoverse - Quest Designer

HoYoverse

Singapore (On-Site)
4 Months ago
binance - QA Engineer

binance

Dubai, Dubai, United Arab Emirates (Remote)
5 Months ago
Lionbridge Games - Test Lead

Lionbridge Games

Mexico City, Mexico City, Mexico (On-Site)
3 Months ago
legion - Director, Quality Assurance

legion

Bucharest, Bucharest, Romania (Hybrid)
1 Month ago
smartbear - Major Account Executive - Test Hub

smartbear

Somerville, Massachusetts, United States (On-Site)
2 Months ago
virtous games - Junior Dev QA

virtous games

Prague, Prague, Czechia (On-Site)
1 Month ago

Get notifed when new similar jobs are uploaded

Similar Skill Jobs

Kyruus Health - Senior Data Architect

Kyruus Health

United States (Remote)
3 Months ago
Cadence - Lead Software Engineer (Agentic AI)

Cadence

Cambridge, England, United Kingdom (Hybrid)
2 Months ago
Cred - People Business Partner

Cred

Bengaluru, Karnataka, India (On-Site)
2 Months ago
Sporty - VIP Manager, Football.com

Sporty

South Africa (Remote)
1 Month ago
hogarth - SDET - Software Development engineer in Test

hogarth

Sunnyvale, California, United States (Hybrid)
2 Months ago
MiQ - Finance Executive, Greater China

MiQ

Hong Kong (On-Site)
1 Month ago
Tesla - Deskside Support Technician

Tesla

North Holland, Netherlands (On-Site)
5 Months ago
Sprinkler - Senior Software Development Engineer, QA

Sprinkler

Gurugram, Haryana, India (On-Site)
1 Month ago
LeoVegas - CRM Manager - Danish Speaking

LeoVegas

Sliema, Malta (Hybrid)
2 Months ago
Windranger - Business Growth Manager

Windranger

(Remote)
4 Months ago

Get notifed when new similar jobs are uploaded

Jobs in Hazelwood, Missouri, United States

Noetic - Senior Level Cyber Analyst

Noetic

Huntsville, Alabama, United States (On-Site)
1 Month ago
Apple - ASIC Design & Integration Engineer

Apple

Sunnyvale, California, United States (On-Site)
1 Month ago
NVIDIA - Senior Firmware Bringup Engineer

NVIDIA

Santa Clara, California, United States (On-Site)
3 Months ago
Riot Games - Principal Animation Artist - Unpublished R&D Product

Riot Games

Los Angeles, California, United States (On-Site)
4 Months ago
appzen - Program Manager – Implementation, Professional Services

appzen

San Jose, California, United States (On-Site)
4 Weeks ago
Trackman - Customer Service Specialist

Trackman

Phoenix, Arizona, United States (On-Site)
3 Months ago
Apple - Client Software Engineer - iOS/macOS - ASE

Apple

San Diego, California, United States (On-Site)
2 Months ago
bytedance - Senior/Tech Lead AI/LLM Network Software Development Engineer - Seattle

bytedance

Seattle, Washington, United States (On-Site)
9 Months ago
Aftershock Media Group - Account Manager, Influencer Marketing - English & Mandarin Fluent

Aftershock Media Group

United States (Remote)
2 Months ago
Dentsu - Senior Associate, Digital

Dentsu

New York, United States (Hybrid)
1 Month ago

Get notifed when new similar jobs are uploaded

Quality Assurance Jobs

extreme network - Staff QA Engineer

extreme network

Bengaluru, Karnataka, India (Hybrid)
1 Month ago
Apple - Senior SerDes System Validation Engineer

Apple

San Diego, California, United States (On-Site)
1 Month ago
Merkur gaming  - QA Automation Engineer

Merkur gaming

Noida, Uttar Pradesh, India (On-Site)
2 Months ago
P99 soft - Junior QA Engineer

P99 soft

Hyderabad, Telangana, India (On-Site)
3 Months ago
Nagarro - Associate Staff Engineer, QA Automation

Nagarro

(On-Site)
9 Months ago
Sawhorse Productions - Quality Inspector - Temporary

Sawhorse Productions

Morganton, North Carolina, United States (On-Site)
1 Month ago
Kavalirio - Quality Assurance (QA) Supervisor

Kavalirio

Colorado Springs, Colorado, United States (On-Site)
2 Months ago
whoop - Senior Hardware Quality Engineer (Accessories)

whoop

Boston, Massachusetts, United States (On-Site)
5 Months ago
Scout - Technical Specialist, Project Coordination, Test & Pre-Series Vehicles

Scout

Columbia, South Carolina, United States (On-Site)
1 Month ago
Marvell - Senior Principal Validation Engineer - SERDES

Marvell

Santa Clara, California, United States (On-Site)
2 Months ago

Get notifed when new similar jobs are uploaded

About The Company

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

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

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

United States (On-Site)

Hazelwood, Missouri, United States (On-Site)

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

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

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

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

Burlington, 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