Validation Engineer

4 Months ago • 4 Years +

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).

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