Lab Instrumentation (Validation/Qualification SMEs)

Boston, MA
Mid Level

We are looking for people who have demonstrated proven success in roles and through abilities in Instrument Qualification, Computerized System Validation, cloud Qualification, Risk management and Quality Management

  • Candidates with 7-10yrs experience who are able to work on-site in Boston, MA.
  • Understand and able to review vendor Qualification document package in line with regulatory requirements
  • Should be aware of USP 1058 – classification of instruments
  • Know how in instrument qualification process and regulations
  • Knowledge on unidirectional, Bidirectional and file based parsing scripts
  • Knowledge on LIMS – Lab vantage, Labware, Watson etc.….
  • Knowledge on Analytical lab instruments like HPLC, GC, GCMS, LCMS, FTIR, UV, Stability chamber, Spectrophotometer, TOC, plate reader ELISA, PCR, Xray   etc.…
  • Know how integration manger works
  • Knowledge on Chromeleon, Empower, ICDAS, SDMS, ELN, LES etc.…
  • Knowledge on Instrument integration using RS232, USB, wireless etc.…
  • Good Knowledge on Calibration of instruments
  • Understanding of key pharmaceutical compliance regulations like Computerized System Validation, 21 CFR part 11, GxP, GAMP 5, SOX IT, Data Privacy, Data Integrity, and Information Security
  • Knowledge on new regulations -Enable innovations, Quality by design, CSA, and AI ML
  • Subject matter expertise in areas such as Quality Management, document management and Change Management
  • Knowledge of Risk management perform root cause analysis on trends and address deviations via preventive, detective, and corrective measures
  • Knowledge and hands on experience conducting periodic or control maturity assessment and Audits
  • Knowledge of various Validation tools and templates used throughout the pharmaceutical industry
  • Technical Writing Experience
  • Work according to SOPs and GMP Regulations
  • Excellent speak up mentality and feedback skills
  • Basics of project leading skills

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