Validation Engineer
USDM Life Sciences
Date: 2 weeks ago
City: Laval, QC
Contract type: Contractor
About USDM
USDM Life Sciences is a premier consulting company with 20+ years of experience assisting heavily regulated biotech, medical device, and pharmaceutical companies with their GxP technologies to accelerate growth. Our deep domain knowledge and technology expertise in life sciences business processes are what set us apart. From strategy to implementation and adoption, we have delivered thousands of GxP projects globally.
As part of the USDM team, you have the opportunity to work with cutting-edge technologies through our many partnerships with companies like Microsoft, Google, Oracle, DocuSign, Box, and many more. From molecule to market, you will help connect technology, people, and data in new ways to generate real-time insights to improve business outcomes for USDM’s clients. Are you ready to make an impact and drive real digital transformation in life sciences?
Founded in Santa Barbara in 1999, USDM has grown to a progressive, global company with 300+ remote employees and offices throughout the US, Canada, and Germany.
Nature and Scope of Job
Seeking an experienced Validation Engineer to support ongoing and upcoming validation projects, focusing on computerized systems such as LIMS and other GxP-regulated platforms. The consultant will collaborate with cross-functional teams to ensure systems are validated in compliance with regulatory standards, including FDA 21 CFR Part 11, EU Annex 11, and GAMP 5 guidelines.
Primary Responsibilities
The working conditions described here are representative of those that must be met by an employee to successfully perform the essential responsibilities and functions of the job and are not meant to be all-inclusive. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential responsibilities and functions of the job.
Unless reasonable accommodations can be made, while performing this job the staff member shall:
USDM Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Disclaimer
This job description is intended to describe the general nature and the level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. USDM Life Sciences reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
For more details about our benefits, visit us here: https://usdm.com/careers
USDM Life Sciences is a premier consulting company with 20+ years of experience assisting heavily regulated biotech, medical device, and pharmaceutical companies with their GxP technologies to accelerate growth. Our deep domain knowledge and technology expertise in life sciences business processes are what set us apart. From strategy to implementation and adoption, we have delivered thousands of GxP projects globally.
As part of the USDM team, you have the opportunity to work with cutting-edge technologies through our many partnerships with companies like Microsoft, Google, Oracle, DocuSign, Box, and many more. From molecule to market, you will help connect technology, people, and data in new ways to generate real-time insights to improve business outcomes for USDM’s clients. Are you ready to make an impact and drive real digital transformation in life sciences?
Founded in Santa Barbara in 1999, USDM has grown to a progressive, global company with 300+ remote employees and offices throughout the US, Canada, and Germany.
Nature and Scope of Job
Seeking an experienced Validation Engineer to support ongoing and upcoming validation projects, focusing on computerized systems such as LIMS and other GxP-regulated platforms. The consultant will collaborate with cross-functional teams to ensure systems are validated in compliance with regulatory standards, including FDA 21 CFR Part 11, EU Annex 11, and GAMP 5 guidelines.
Primary Responsibilities
- Develop and execute validation protocols (IQ/OQ/PQ) for LIMS and other computerized systems.
- Conduct risk assessments and create validation plans in alignment with regulatory requirements.
- Collaborate with IT, Quality Assurance, and laboratory personnel to gather user requirements and ensure system configurations meet business needs.
- Maintain comprehensive documentation to support validation activities and facilitate audits.
- Provide training and support to end-users on validated systems.
- Performs other related duties and assignments as required
- Minimum of 5 years of experience in computerized system validation within the pharmaceutical or biotechnology industry.
- Proficiency in validating LIMS and familiarity with CSV principles. LabVantage LIMS preferred.
- Strong understanding of regulatory requirements (FDA 21 CFR Part 11, EU Annex 11, GAMP 5).
- Excellent communication skills in English; French proficiency is an asset.
- Experience with specific LIMS platforms (e.g.,, LabVantage).
- Knowledge of data integrity principles and electronic records management.
- Ability to work independently and manage multiple validation projects simultaneously.
- Bachelor’s degree in Computer Science, Life Sciences, Engineering, or a related field.
The working conditions described here are representative of those that must be met by an employee to successfully perform the essential responsibilities and functions of the job and are not meant to be all-inclusive. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential responsibilities and functions of the job.
Unless reasonable accommodations can be made, while performing this job the staff member shall:
- Prolonged periods of sitting or standing at a desk and working on a computer in an environmentally controlled home office environment.
- Operate other office productivity machinery, such as a calculator, scanner, or printer.
- Frequently communicate with stakeholders via telephone, email, or instant message. Must be able to exchange accurate information in these situations.
USDM Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Disclaimer
This job description is intended to describe the general nature and the level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. USDM Life Sciences reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
For more details about our benefits, visit us here: https://usdm.com/careers
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