Senior Validation / Quality Engineer

Employer
Bachem
Location
Torrance, CA, US
Posted
Nov 10, 2020
Ref
631579701
Hotbed
Biotech Beach
Required Education
Associate Degree
Position Type
Full time
The Sr. Validation Engineer / Quality Engineering (QE) fulfills a critical role in GMP operations, supporting cleaning validation activities for API and PMO manufacturing, and the qualification of equipment, facilities, utilities. This position will work in close cooperation with Manufacturing, Engineering, and other functional areas to plan and perform validation activities under the Quality Engineering scope of work. This individual must also monitor facility / utility validated systems, plan, write and execute validation/ qualification protocols, reports, and other technical documents, as well as conduct related investigations

Your Tasks:

  • Conduct cleaning validation studies of production labware and equipment using UV/VIS spectrophotometry, wet chemistry, Total Organic Carbon (TOC), pH and conductivity
  • Perform analysis of spike and recovery rinse samples
  • Perform mathematical calculations, interpret results and record observations
  • Independently plan and execute cleaning validation studies, processes and other operations
  • Write validation protocols and final reports, test methods, standard operating procedures, and technical reports
  • Planning, writing and executing qualification protocols (IQ, OQ, PQ) and reports
  • Independently conduct and document investigations related to validation studies
  • Based on validation studies, evaluate and make recommendations for improvements to operations, processes and methods
  • Accountable for the accuracy and validity of testing results
  • Support and assist in internal inspections and audits
  • Perform other related duties as assigned
  • Make safe, efficient and conscious use of instruments, materials and other resources provided
  • Work and communicate with different associates within the company to ensure timely completion of assigned tasks and projects
  • Adherence to cGMP and safety procedures and contribute to GMP systems improvements


Your Profile:

  • Bachelors' degree in science discipline (chemistry, biochemistry, organic chemistry, biology, microbiology, chemical engineering or equivalent) required
  • Minimum of 5 years of hands-on experience in cleaning validation or in a quality control analytical laboratory in a GMP/GDP environment required, and in planning, writing and executing qualification protocols (IQ, OQ, PQ) and reports
  • Understanding and knowledgeable of cleaning validation requirements for pharmaceutical industry
  • Knowledge of and ability to perform MAC calculation for APIs
  • Experience with developing coupon spike and recovery studies for cleaning validation
  • Understanding of test method validation per ICH Q2
  • Experience with validation / monitoring of clean pharmaceutical utility systems, including purified water, Nitrogen systems and cold storage units
  • Experience in a cGMP environment required
  • Experience in an industrial chemistry laboratory
  • Knowledge of the chemical composition, structure, and properties of substances and of the chemical processes and transformations that they undergo. This includes uses of chemicals and their interactions, danger signs, production techniques, and disposal methods
  • General lab instrumentation knowledge and operation experience
  • Capable of working methodically and accordingly adhering to rules and regulations
  • Entering or recording information in written or electronic form
  • Using hands and arms in handling, installing, positioning, and moving materials, and manipulating things
  • Basic computer knowledge, including Microsoft Word, Excel, PowerPoint and Visio
  • Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment
  • Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues
  • Detail oriented with the ability to troubleshoot and resolve problems
  • Ability to work independently and manage one's time
  • Communicate effectively and ability to function well in a team environment.
  • Coach and mentor validation personnel as well as oversee the activities of contractors / vendors (as necessary)


Preferred:

  • Exprience with planning and execution of cleaning validation of prduction lab glassware and equipment including performance of validation studies, writing validation protocols and reports and other technical documents, as well as conducting validation related investigations.
  • Experience with developing coupon spike and recovery studies for cleaning validation
  • Master's degree in science related field (engineering, chemistry, biology or equivalent)
  • Experience with Qualification (IQ, OQ, PQ)
  • Experience with Lean Six Sigma methods: Root cause analysis, failure mode analysis and analyzing / organizing complex technical problems


Nearest Major Market: Los Angeles