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QC Test Method Development Engineer
QC Test Method Development EngineerNanda Technologies • Thousand Oaks, CA, United States
QC Test Method Development Engineer

QC Test Method Development Engineer

Nanda Technologies • Thousand Oaks, CA, United States
7 days ago
Job type
  • Full-time
  • Quick Apply
Job description

Job code : -6861-2-11 / 17

Hi All,

Urgent need in Thousand Oaks for a QC Test Method Development Engineer.

QC Test Method Development Engineer

Term- 6 months+

Onsite in Thousand Oaks, CA

HPLC is a must and candidates will be asked about the types.

We are seeking an experienced consultant to lead the quality control (QC) instrumentation validation and analytical method lifecycle activities within a regulated life sciences environment. This role involves hands-on work with analytical instrumentation, method validation, and data integrity to ensure compliance with global regulatory expectations.

Essential Duties and Responsibilities :

  • KNEAT experience (electronic validation system)
  • Develop and execute test method transfers / validation / verification protocols for QC Methods. Examples include :

HPLC methods

  • Osmolality assay
  • SDS Page assay
  • Develop method SOPs for multiple materials
  • Demonstrated method troubleshooting capability
  • Validation of quality control instruments (spectrometers) including the following :
  • Review and update User Requirements Specifications (URS) and generate system design and configuration specifications

  • Review and update instrument operations and maintenance Standard Operating Procedures (SOPs)
  • Manage / support vendor instrument IOQ process and develop / execute appropriate PQ protocols
  • Author PQ final reports including trace matrices and data integrity assessments
  • Requirements :

  • Bachelor's Degree or superior
  • Method development and method validation
  • 5 years of manufacturing, quality or engineering in the biotech or pharmaceutical industry with a BS / BA Degree in Science / related field
  • Strong understanding of the underlying principles of chemistry, as well as knowledge of laboratory safety and best practices
  • Strong experience with ICH Q2 method qualification / validation requirements, USP, EP, and JP Pharmacopeia
  • Hands-on analytical instrumentation experience is preferred
  • Knowledge of Good Manufacturing Practices (also cGMP) compliance requirements for Quality Control Laboratories, and experience with a wide range of analytical techniques
  • Strong verbal and written communication skills
  • Create a job alert for this search

    Test Development Engineer • Thousand Oaks, CA, United States

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