Quality Engineer

Employer
Bachem
Location
Torrance, CA
Posted
Apr 27, 2022
Ref
767109001
Hotbed
Biotech Beach
Required Education
Associate 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 Engineering / Senior Quality Engineer 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 3years 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 requried.
  • 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

  • Experience with planning and execution of cleaning validation of production 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.

Candidates for positions as US employees of Bachem Americas, Inc. (“Company”) must be in the process of or fully vaccinated against the COVID-19 virus and provide the Company with proof of vaccination as a condition of employment, except for U.S. employees who request and qualify under applicable law for disability and religious accommodation from the COVID-19 vaccine mandate. An applicant who receives an offer of employment from the Company for a position as a U.S employee will be required to provide proof of vaccination status, or request and receive a disability or religious accommodation for which the applicant is entitled under applicable law, before their first day of employment or any later deadline specified by the Company in the offer letter. The Company is an equal opportunity employer and provides employment opportunities and makes employment decisions without regard to an individual’s disability, religion or on any other basis prohibited by law.