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

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

QUALIFICATIONS

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

EDUCATION & CERTIFICATIONS

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

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.

Primary Responsibilities

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