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Job Title: Senior QC Instrumentation & Calibration Engineer
Role Overview
We are seeking an ownership-driven Senior QC Instrumentation & Calibration Engineer to take full operational accountability for the maintenance, validation, and compliance verification of our Quality Control Laboratory instruments. In this senior individual contributor role, you will lead the equipment quality program-managing full-lifecycle asset readiness, executing hands-on troubleshooting, and coordinating complex installations, qualifications, and preventive maintenance cadences with external vendors.
Serving as the critical bridge between laboratory operations and regulatory standard frameworks, you will author strict compliance protocols and ensure all analytical equipment remains in absolute alignment with FDA, cGMP, and data integrity guidelines.
Key Responsibilities
Equipment Lifecycle & Qualification Frameworks
• Validation Protocols: Draft, execute, and maintain IQ/OQ/PQ (Installation, Operational, and Performance Qualification) protocols for complex analytical laboratory instruments under the guidance of Quality leadership.
• SOP Authoring: Prepare and continuously optimize detailed Standard Operating Procedures (SOPs) governing calibration, preventive maintenance, and general system operations.
• Asset Governance: Manage full instrument asset lifecycles, monitoring instrument usage, overseeing work orders for technical repairs, and maintaining clean validation documentation.
• Capital Project Execution: Lead capital expenditure ($CAPEX$) projects focused on instrument procurement, technical onboarding, and installation phases to meet strict facility output timelines.
Technical Maintenance, Troubleshooting & Vendor Logistics
• Technical Repairs: Perform advanced troubleshooting, diagnostic isolation, and hands-on repairs of analytical laboratory instruments to minimize workflow disruptions.
• Vendor Operations: Serve as the central point of contact for all external laboratory instrument manufacturers and third-party service providers; coordinate schedules, obtain parts-and-labor quotes, and audit technical work.
• Downtime Management: Monitor real-time equipment availability, actively alerting Quality Control management regarding critical instrument downtime and estimated restoration paths.
Regulatory Compliance & Quality Assurance
• cGMP/GLP Auditing: Review and verify laboratory instrument logbooks, ensuring that day-to-day instrument utilization remains in strict compliance with current Good Manufacturing Practices (cGMP) and Good Laboratory Practices (GLP).
• Investigation Support: Assist multi-disciplinary teams during instrument-related investigations, providing technical data to close out assigned Deviations and CAPAs (Corrective and Preventive Actions).
• Change Control Integration: Coordinate closely with Quality Assurance (QA) to execute formal Change Controls ($CR$) related to laboratory systems and instrumentation modifications.
• Safety & Environment: Maintain a pristine, secure, and compliant laboratory environment, applying strict safety awareness protocols across all testing environments.
Qualifications & Requirements
Minimum Qualifications
• Education: Bachelor's degree in Chemistry, Biochemistry, or a closely related scientific/engineering discipline.
• Experience Baseline: Minimum of 3 to 5 years of hands-on technical experience working directly within a Pharmaceutical Quality Control laboratory environment.
• Compliance Depth: Strong, foundational understanding of cGMP/GLP environments and an cross-functional familiarity with 21 CFR Part 11 guidelines (data integrity and electronic records).
• Communication: Exceptional oral and written technical writing skills, with a proven ability to translate complex equipment parameters into compliant SOPs.
Preferred Qualifications
• Proven project management experience directing laboratory instrumentation capital engineering projects.
• Hands-on familiarity with Computer Systems Validation (CSV) protocols within automated laboratory environments.
• Deep technical familiarity with enterprise-grade HPLC/UPLC systems and chromatography data software (CDS) platforms.
Equal Opportunity Employer / Disabled / Protected Veterans
The Know Your Rights poster is available here:
https://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12.pdf
The pay transparency policy is available here:
https://www.dol.gov/sites/dolgov/files/ofccp/pdf/pay-transp_%20English_formattedESQA508c.pdf
For temporary assignments lasting 13 weeks or longer, AllSTEM Connections is pleased to offer major medical, dental, vision, 401k and any statutory sick pay where required.
We are committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation for any part of the employment process, please contact your staffing representative who will reach out to our HR team.
AllSTEM Connections participates in the E-Verify program in certain locations as required by law. Learn more about the E-Verify program.
https://e-verify.uscis.gov/web/media/resourcesContents/E-Verify_Participation_Poster_ES.pdf
We also consider for employment qualified applicants regardless of criminal histories, consistent with legal requirements, including, if applicable, the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance. Pursuant to applicable state and municipal Fair Chance Laws and Ordinances, we will consider for employment-qualified applicants with arrest and conviction records, including, if applicable, the San Francisco Fair Chance Ordinance. For Los Angeles, CA applicants: Qualified applications with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
Additional Skills
(none specified)
AllSTEM Representative Contact Info
Account Executive:
Nichols
Branch Phone:
(909) 244-1777
Location:
Ontario, CA