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Validation Engineeer II

Company: Bachem
Location: Vista
Posted on: November 12, 2021

Job Description:

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 TidesIn order to continue our organic growth, we are constantly looking for talent.Your ResponsibilitiesThe Validation Engineer II fulfills a critical role in GMP operations. This individual must plan and execute validation studies, write validation protocols, reports and other technical documents, as well as conduct validation related investigations. The incumbent is responsible for managing the cleaning validation activities in a GMP environment including cleaning cycle development, execution of protocols and review and approval of reports. The incumbent will contribute to improvements in operations, processes and methods.Your Tasks

  • Provide equipment, facilities/utilities qualification guidance and strategy during project planning and development phases
  • Independently develop cleaning validation strategy for equipment and parts
  • Develop and execute cleaning validation protocols and generate validation reports
  • Independently plan and execute validation studies for equipment, facilities/ utilities and cleaning
  • Manage contractors performing equipment and system qualifications
  • Write validation protocols, validation final reports, Standard Operating Procedures (SOPs), and technical reports
  • Review and approve validation documentation (requirements specifications, risk assessments, validation plans, IQ, OQ, and related reports, and validation summary reports, etc.) using defined procedures
  • Independently conduct and document investigations related to validation activities
  • Contribute to GMP systems improvements
  • Train operations staff on protocols, procedures and technical details related to systems, equipment and cleaning processes
  • Support the change control process by reviewing proposed changes, performing risk assessments, and assessing the adequacy of verifications and validations
  • Demonstrates commitment to the development, implementation and effectiveness of Quality Management System per ISO, FDA, and other regulatory agencies requirementsYour Profile
    • Bachelor's Degree in science related field (Engineering, chemistry, biology or equivalent)
    • Minimum of 4 years of pharmaceutical validation experience (cleaning, equipment and facilitates/ utilities)
    • 2-4 years of related experience in Engineering, manufacturing or quality
    • Experience with root cause analysis, failure mode analysis, verification and validation
    • Experience in drug GMP manufacturing
    • Experience in writing standard operating procedures and technical reports
    • Experience in validation, particularly cleaning validation
    • Excellent written and oral communication skills
    • Basic computer knowledge, including Microsoft Word, Excel and PowerPoint
    • 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 environmentPreferred:
      • Master's Degree in science related field
      • Six Sigma Green or Black Belt We Offer You will be part of a motivated team overseeing the entire development cycle of respective APIs. If you are looking for a new challenge and want to join a motivated team in an internationally renowned company, you should seize this opportunity.

Keywords: Bachem, Vista , Validation Engineeer II, Other , Vista, California

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