Senior QC Instrumentation & Calibration Engineer (Pharmaceutical)

TL;DR

Senior QC Instrumentation & Calibration Engineer (Pharmaceutical): Managing the maintenance, validation, and compliance of Quality Control Laboratory instruments with an accent on IQ/OQ/PQ protocols and regulatory alignment. Focus on executing hands-on troubleshooting, coordinating vendor logistics, and ensuring strict adherence to FDA and cGMP guidelines.

Location: Onsite in Rensselaer, NY

Salary: $92,000 – $138,000

Company

hirify.global is a staffing agency providing technical and scientific personnel for specialized industry roles.

What you will do

• Draft and execute IQ/OQ/PQ validation protocols for complex analytical laboratory instruments.
• Author and optimize Standard Operating Procedures (SOPs) for calibration and preventive maintenance.
• Perform advanced troubleshooting, diagnostic isolation, and hands-on repairs to minimize downtime.
• Coordinate schedules, quotes, and audit technical work with external manufacturers and third-party providers.
• Ensure all instrument utilization remains in strict compliance with cGMP, GLP, and 21 CFR Part 11.
• Lead capital expenditure (CAPEX) projects for instrument procurement and technical onboarding.

Requirements

• Bachelor’s degree in Chemistry, Biochemistry, or a related scientific/engineering discipline.
• 3 to 5 years of hands-on technical experience in a Pharmaceutical Quality Control laboratory.
• Foundational understanding of cGMP/GLP environments and 21 CFR Part 11 guidelines.
• Exceptional oral and written technical writing skills for compliant SOP authoring.
• Must be based in or able to work onsite in Rensselaer, NY.

Nice to have

• Experience directing laboratory instrumentation capital engineering projects.
• Familiarity with Computer Systems Validation (CSV) protocols.
• Deep technical expertise with HPLC/UPLC systems and chromatography data software (CDS) platforms.

Culture & Benefits

• Major medical, dental, and vision insurance for assignments lasting 13+ weeks.
• 401k retirement plan options.
• Statutory sick pay where required.
• Commitment to reasonable accommodations for individuals with disabilities.