A Calibration Technician is responsible for the routine inspection, testing, maintenance and repair of instruments and manufacturing equipment. The purpose of the calibration technician role is to ensure the accuracy of the measurements taken using this equipment.
About Ascendia Pharmaceutical Solutions About Ascendia Pharmaceutical Solutions:
Ascendia is a specialty pharmaceutical Research and Development CDMO company dedicated to developing enhanced formulations of existing drug products and enabling formulations for pre-clinical and clinical stage drug candidates. Ascendia specializes in creating formulations for poorly-water soluble molecules using nano-particle technologies. Ascendia assesses the feasibility of a broad array of formulation options to improve a drug's bioavailability and solubility. Ascendia's technologies include nano-emulsions, amorphous solid dispersions, nano-particles, injectables, and oral controlled release. Ascendia provides development and testing services - from discovery-stage molecules to life-cycle-management projects - creating formulation solutions with enhanced biopharmaceutical properties suitable for clinical scale-up. The mission of our company is to provide customized formulation solutions to "salvage" difficult compounds and to create advanced medicines to help patients "prevail" over their disease and enhance quality of life. About the Role We are seeking an experienced Metrologist to lead and support calibration, metrology, equipment documentation, and compliance activities across a pharmaceutical CDMO operation. This role supports analytical laboratories, sterile manufacturing, non-sterile manufacturing, utilities, facilities, and GMP production areas by ensuring equipment and instruments remain calibrated, properly documented, inspection-ready, and aligned with regulatory and client expectations. The Metrologist will provide technical leadership for the calibration program, maintain the master equipment list in DOT Compliance, oversee equipment and instrument documentation files, support out-of-tolerance investigations, coordinate vendor activities, and partner with Quality, Engineering, Manufacturing, and Laboratory teams. Key Responsibilities Lead day-to-day calibration and metrology activities for laboratory, manufacturing, utility, facility, and support equipment. Maintain and periodically reconcile the master equipment list in DOT Compliance to ensure accurate equipment status, location, ownership, calibration requirements, preventive maintenance requirements, criticality, and lifecycle status. Oversee complete and audit-ready equipment and instrument documentation files, including calibration certificates, service reports, manuals, qualification records, preventive maintenance records, change records, deviation records, and retirement documentation. Review calibration certificates, cleanroom HEPA filter certifications, service reports, and vendor documentation for technical accuracy, GMP compliance, traceability, and completeness. Coordinate internal and external calibration, service, repair, and preventive maintenance activities with minimal impact to laboratory and manufacturing operations. Provide technical support for analytical laboratory instruments, sterile manufacturing equipment, non-sterile manufacturing equipment, utilities, cleanroom support systems, and process instrumentation. Lead or support investigations related to out-of-tolerance results, missed calibrations, equipment failures, documentation gaps, deviations, CAPAs, change controls, and audit observations. Assess calibration impact and equipment risk using equipment history, criticality, intended use, product impact, and process requirements. Recommend calibration interval changes, documentation improvements, and process enhancements based on trends, risk, and equipment performance. Support equipment onboarding, relocation, qualification, modification, retirement, and lifecycle documentation. Serve as a subject matter resource during internal audits, client audits, and regulatory inspections. Partner with Quality Assurance, Quality Control, Formulations, Analytical, Manufacturing, Engineering, and external vendors to resolve equipment and documentation issues. Ensure activities are performed in accordance with GMP, GDP, data integrity expectations, site procedures, safety requirements, and applicable regulatory standards. Support / generate / execute equipment qualification documents as required. Qualifications High school diploma or equivalent required. Associate degree, technical certification, military technical training, or equivalent experience in metrology, instrumentation, engineering technology, life sciences, or a related technical field preferred. Typically, 5+ years of experience in metrology, calibration, instrumentation, maintenance, engineering support, or equipment lifecycle documentation. Experience in pharmaceutical, biotechnology, medical device, sterile manufacturing, non-sterile manufacturing, laboratory, or CDMO environment preferred. Strong working knowledge of GMP, GDP, data integrity, calibration practices, equipment lifecycle documentation, and audit expectations. Experience reviewing calibration certificates, service reports, equipment files, SOPs, technical manuals, and qualification records. Experience supporting out-of-tolerance investigations, deviations, CAPAs, change controls, and audit responses. Strong organizational, technical writing, communication, problem-solving, and follow-up skills. Ability to work independently, prioritize competing needs, and coordinate across multiple departments and production schedules. Preferred Experience Experience using DOT Compliance or similar calibration, maintenance, asset management, or equipment compliance systems. Experience maintaining master equipment lists and performing periodic equipment record reconciliations. Experience supporting analytical instruments such as HPLC, GC, balances, pH meters, pipettes, dissolution equipment, incubators, refrigerators, freezers, and temperature/humidity monitoring equipment. Experience supporting manufacturing equipment such as scales, tanks, mixers, filling equipment, autoclaves, washers, pressure instruments, temperature instruments, cleanroom equipment, and utility systems. Experience in sterile / aseptic processing environments, including gowning, cleanroom behavior, and contamination control practices. Knowledge of NIST-traceable calibration, calibration interval justification, risk-based equipment classification, and equipment qualification documentation. Knowledge of equipment qualification and the document lifecycle. Join our team as a Metrologist to play a crucial role in ensuring the integrity of our pharmaceutical components through precise measurement and rigorous quality assurance practices!
Pay:
$65,000.00 - $90,000.00 per year
Benefits:
401(k) 401(k) matching Dental insurance Flexible schedule Flexible spending account Health insurance Life insurance Paid time off Vision insurance
