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IQVIA

Runs drug trials and sells health data to pharma

Senior Metrology/Liquid Chromatography Mass Spectrometry Engineer

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeIndianapolis, IN, USAIn-person

About the Job

Requirements

  • A bachelor's degree is required, although an equivalent combination of education, training, and experience may be accepted in lieu of a degree.
  • Four years of experience in a laboratory environment.
  • Hands-on experience calibrating and repairing measuring and test equipment, including documenting preventative maintenance programs.
  • Experience performing preventative maintenance and troubleshooting for analytical instrumentation, including liquid chromatography tandem mass spectrometry systems.
  • Proficiency with Windows and Microsoft Office applications, particularly Microsoft Word and Excel.
  • Experience evaluating, onboarding, and qualifying new laboratory equipment and validating associated instrument software.
  • Ability to analyze, interpret, and communicate complex technical information, engineering documents, and equipment schematics.
  • Root cause analysis, quality management, project management, and process improvement capabilities.
  • Written and verbal communication skills, including the ability to present relevant technical information to clients and stakeholders.
  • Organizational skills and attention to detail, with the ability to manage multiple tasks independently.
  • Everyday leadership and the ability to mentor colleagues and build effective relationships with coworkers, managers, clients, contractors, and vendors.
  • Ability to complete projects and deliverables within established expectations and applicable regulatory requirements.
  • Applicable certifications and licenses as required by local regulations.

Responsibilities

  • Install, qualify, calibrate, verify, maintain, troubleshoot, and coordinate repairs for laboratory equipment and analytical instrumentation.
  • Perform preventative maintenance on analytical instruments, including Sciex liquid chromatography tandem mass spectrometry systems, and coordinate vendor maintenance when required.
  • Maintain equipment lifecycle documentation, inventories, preventative maintenance programs, risk assessments, gap analyses, and standard operating procedures.
  • Partner with Facilities Management, Information Technology, Supply Chain, Quality, and external vendors to support equipment infrastructure, software validation, repairs, and inventory requirements.
  • Lead the onboarding and qualification of new equipment and instrumentation in accordance with applicable standards and standard operating procedures.
  • Serve as a subject matter expert during audits and inspections, respond to inquiries, and support resolution of quality incidents and corrective and preventative actions.
  • Manage laboratory initiatives, business continuity planning, emergency response coverage, functional metrics, and equipment evaluation projects.
  • Train, mentor, and guide employees and junior-level staff while identifying opportunities for process, quality, and safety improvements.

About the Company

IQVIA

Runs drug trials and sells health data to pharma

IQVIA runs clinical trials for drug, biotech and medical device companies and sells them the health data, software and analytics they use to develop and market treatments. Its research arm designs studies, recruits trial sites and patients, and manages trials through to regulatory filing. Its commercial arm sells market data, consulting and software that pharma sales and marketing teams use to plan product launches. Clients pay through multi-year service contracts and data and software subscriptions. IQVIA was formed in 2016 when clinical research firm Quintiles merged with health data company IMS Health, and it is based in Durham, North Carolina.

Company size
10,001+
Company stage
IPO
Headquarters
Durham, NC
Founded
1998

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