Validation Engineer - Instrument Qualification at USDM Life Sciences

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 sets 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

USDM is seeking an experienced Instrument Qualification Consultant to join our team. The successful candidate will be responsible for executing change control and ensuring the qualification of analytical instruments in a regulated laboratory environment. These instruments will be integrated with MODA and Labware systems, so experience with these platforms is essential. The role requires a thorough understanding of analytical instrument qualification, data integrity, and compliance with regulatory standards such as GxP, 21 CFR Part 11, and EU Annex 11.

 Primary Responsibilities

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• Perform qualification activities for analytical instruments, including IQ/OQ/PQ (Installation, Operational, and Performance Qualification) following established protocols and regulatory guidelines.
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• Manage and execute change control processes related to instrumentation and ensure all changes are documented, reviewed, and approved in compliance with internal and regulatory requirements.
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•  Oversee the integration of laboratory instruments with MODA (Manufacturing Operations Data Analytics) and Labware LIMS, ensuring proper connectivity, data capture, and integrity across systems.
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• Draft, review, and execute qualification protocols and reports for analytical instruments, ensuring all documentation is in line with GxP standards and internal SOPs.
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• Ensure all qualified instruments and systems comply with data integrity requirements, including audit trails, electronic signatures, and access control.
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• Ensure qualification activities comply with regulatory standards (GxP, 21 CFR Part 11, EU Annex 11, etc.) and company-specific policies.
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• Work closely with laboratory, quality, and IT teams to ensure seamless qualification and integration processes.
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• Maintain detailed records of qualification activities, provide status reports, and support regulatory audits/inspections.
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Additional Responsibilities

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• Other duties as assigned.

Qualifications

• Minimum of 3-5 years of experience in analytical instrument qualification in a GMP/GxP-regulated environment.
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• Proficiency in executing and managing change control processes.
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• Hands-on experience with the integration of laboratory instruments into MODA and Labware LIMS platforms.
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• Strong understanding of regulatory requirements, including GxP, 21 CFR Part 11, EU Annex 11, and data integrity principles.
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• Ability to write clear, concise qualification protocols, reports, and technical documents.
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• Excellent communication, organization, and problem-solving skills.
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• Familiarity with other laboratory data management systems or software integrations (preferred).
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• Experience with audit support and participation in regulatory inspections (preferred).
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• Certification or training in project management, validation, or quality assurance (preferred).
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Education & Certifications

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• Bachelor’s degree in a related scientific discipline (e.g., Chemistry, Biology, Engineering) or equivalent work experience.
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Working Conditions

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:

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• Prolonged periods of sitting or standing at a desk and working on a computer in an environmentally controlled home office environment.
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• Operate other office productivity machinery, such as a calculator, scanner, or printer.
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• Frequently communicate with stakeholders via telephone, email, or instant message. Must be able to exchange accurate information in these situations.
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• Laboratory environment requiring interaction with various stakeholders, including laboratory staff, IT, and quality assurance.
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• Occasional travel may be required for site visits, audits, or consultations.
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Equal Opportunity Statement

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. 

Compensation

Salary/Hourly Rate Range (W2): USD 55.00 – 75.00

The base salary/hourly rate range represents the anticipated low and high end of the USDM’s compensation range for this position. Actual salaries/hourly rates will vary and will be based on various factors, such as the candidate’s qualifications, skills, competencies, and proficiency for the role. The compensation described above is subject to change and could be higher or lower than the range described based on market survey data or budget.
 

Full-time employees are eligible for health, vision, and dental insurance, life insurance, short and long-term disability, hospital indemnity, accident, and critical care coverage. Both full and part-time employees, who are at least 21 years of age, are eligible to participate in USDM's 401k plan. Full and part-time employees may be eligible for paid time off.  All employees are eligible for USDM's rewards and recognition program.

For more details about our benefits, visit us here:  https://usdm.com/careers