Specialist, Metrology

About the role

The Boulder Site is home to the specialized technical operations/CMC team for oligonucleotides and RNAi therapeutics. The CMC team works alongside Quality, Regulatory, Technical Operations and RNAi Early Development professionals at our Boulder, Colorado facility and works closely with our teams in Lexington, Massachusetts. Together, we are driving change. Are you ready to make a difference.

Responsibilities

• Works in a safe & environmentally responsible way
• Drive the creation & approval of calibration specifications & methods for the site
• Acts as SME to support equipment & system owners in all aspects related to instrumentation (cal specs, problem solving, instrument selection, deviations, etc.)
• Coaches technicians and site staff in training, problem solving & improvement of Metrology
• SME for deviations related to Metrology/Calibration process
• Identifies & drives improvements in calibration methods, standards, reliability & specifications to fulfill customer needs & to align with overall site strategy aligning with corporate standards
• Drives alignment & standardization for calibration specifications, methods & Blue Mountain Ram calibration record keeping
• Site responsible & lead for Metrology initiatives
• Lead & participate in planning & execution of larger &/or complex activities related to Metrology, including optimization & investment projects
• Serves as SME by leading initiative to create internal Metrology Lab, including creation of Calibration annualBudgets
• Metrology SME for audit & inspection. Responsible for preparedness & participation
• Other accountabilities, as assigned

Qualifications

• Bachelor's degree from an accredited university and 2+ years of experience required. Equivalent experience requirements for advanced degrees would be a Master's degree and 0+ years of experience
• Degree in related engineering or science discipline or equivalent combination of education & metrology experience required
• Experience in pharmaceutical calibrations/metrology or other highly regulated industry preferred
• Experience in planning maintenance &/or calibration activities required
• Experience investigating GMP calibration or instrument failures required
• Experience in preparing technical instructions/procedures required
• Demonstrated expertise in measurement instrumentation theory & method development required
• Demonstrated expertise in calibrating pharmaceutical or other highly regulated instrumentation required
• Working knowledge of cGMPs, corporate & site level requirements & procedures required
• Demonstrated ability to write technical documents, instructions & reports preferred
• Demonstrated ability to present technical information to others required
• Working knowledge of Word & Excel software applications preferred
• Working knowledge of handling & accounting for measurement uncertainty preferred
• Demonstrated ability to manage multiple tasks & responsibilities with competing priorities preferred
• Demonstrated systematic approach to problem solving & troubleshooting preferred