Laboratory Equipment Validation Engineer
Insight Global
Skills Required:
- Bachelor’s Degree in Life Sciences, Chemistry, Engineering or a relevant field of study from an accredited university required
- Minimum of two (2) years of instrument, laboratory validation, or engineering experience in the pharmaceutical industry or related field required
- Experience in writing & executing validation protocols
- Experience in managing projects preferred
- Experience with electronic validation systems (TIMS) and SAP PM and QM module a plus
- Working knowledge of GMPs required
- Ability to act as project manager driving & implementing equipment projects required
- Demonstrated ability to write & present technical/scientific documents & reports preferred
- Understanding of QC equipment/systems, end user functionality & life-cycle management a plus
Job Description:
Insight Global is seeking a QC Laboratory Validation engineer to plan, manage & perform laboratory validation activities. Routine review of laboratory validation procedures & completed validation protocols for accuracy, completeness & maintenance of validated state per corporate requirements. Change control responsible for QC equipment. Collaboration & coordination with IT, metrology & other key stakeholders to ensure the right quality, cost & timely completion of all deliverables. This includes work in the QC spaces in Finished Production (FP) and Warehouse/Interlogistics (WH/IL) spaces at the expansion facility as well as QC equipment qualification. The scope of work includes:
- QC Equipment in Scope
- Kardex Remstar Verticle Carousel Storage Units
- Walk-in Refrigerators
- Reach-In Refrigerators/Freezers
- EyeC Proofiler Systems
- Dose Accuracy Instrumentation
- Zwick AutoTesters and Pentesters
- FT-IR/NIR
- Raman Spectrophotomers
- Waters HPLC/UPLC
- Atomic Absorption Spectrophotometers
- Malvern Particle Size Analyzers
- Total Organic Carbon Analyzers
- HIAC Particle Size Analyzers
- Downflow Booths/Fume Hoods
- Ovens/Muffle Furnaces
- Thermometers
- Light Meters
- Balances
- Pipettes
- Milli-Q Water Systems
- pH/Conductivity Meters
- Glasswashers
- Other Benchtop Equipment as defined by the project
Vacancy posted 1 day ago
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