Quality Engineer II

Employer
Bachem
Location
Torrance, CA
Posted
May 27, 2021
Ref
670020701
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time

The Swiss based Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of pepTides and oligonucleoTides. As a full service provider Bachem offers products for clinical development and commercial applications as well as a comprehensive catalog and exclusive custom synthesis. With 50 years of experience and subsidiaries in Switzerland, the United States, the United Kingdom and Japan, Bachem is the partner of choice for the biotech and pharma industry worldwide.
Bachem. Leading Partner in Tides

In order to continue our organic growth, we are constantly looking for talent.

Your Responsibilities
The Quality Engineer II (QE) fulfills a critical role in GMP operations, supporting the qualification and validation of equipment, facilities, utilities, and cleaning validation activities for API and PMO manufacturing. 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 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:

  • Oversee or independently plan and execute qualification (IQ, OQ, PQ), validation activities under the Quality Engineering scope of work
  • Plan and perform required periodic re-validation / re-qualification activities
  • Support cleaning validation / verification activities
  • Generate, support and review change controls, as required
  • Generate / address deviations, and CAPAs
  • Develop, plan and perform cold storage unit validation / temperature mapping using existing data loggers, including managing the calibration of the units
  • Review periodic utility system verifications / monitoring (purity test), and cleanroom pressure differential monitoring
  • Develop and execute cleaning validation protocols and generate validation reports per established acceptance limits and criteria
  • Perform QA review of equipment calibration documents
  • Draft SOPs and technical reports
  • Train operations staff on protocols, procedures and technical details related to systems, equipment and cleaning processes
  • Demonstrate commitment to the development, implementation and effectiveness of Quality Management System per ISO, FDA, and other regulatory agencies requirements.
  • Contribute to GMP systems improvements

Your Profile:

  • Bachelor’s Degree in engineering or science related field (chemistry, biology or equivalent)
  • Minimum of 3 years pharmaceutical validation experience, including experience in planning, writing and executing qualification protocols (IQ, OQ, PQ), re-qualification protocols and reports
  • Experience in validation / monitoring of pharmaceutical facility and utility systems
  • Experience with data logger equipment
  • Experience in writing standard operating procedures (SOP) and technical reports
  • Experience in cGMPs manufacturing requirements; including deviations, CAPAs, change controls, and equipment calibration requirements
  • Excellent written and oral communication skills
  • 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


Preferred:

  • Master’s degree in engineering or science related field (chemistry, biology or equivalent)
  • Experience in cleaning validation
  • Experience in automation / controls