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Biopharmaceutical Process Expert

4 weeks ago

Holly Springs, United States Amgen Full time

**Key Responsibilities**

This critical role requires an accomplished Senior Process Engineer to contribute their expertise in Biopharmaceutical process equipment and facilities. Your primary duties will include:

  • Leading a team to develop and implement process improvements, upgrading equipment, and validating new systems.

  • Creating and maintaining documentation, guidelines, and procedures for equipment operation, maintenance, and troubleshooting.

  • Ensuring adherence to GMP quality standards and guiding others in applying scientific principles to equipment design and implementation.

  • Participating in cross-functional teams to assess risk, identify opportunities for improvement, and prioritize initiatives.

  • Delivering high-quality work products through effective project management and leadership techniques.

Requirements**

To succeed in this role, candidates must possess:

  • A Doctorate degree OR Master's degree with 3 years of Engineering experience OR Bachelor's degree with 5 years of Engineering experience OR Associate's degree with 10 years of Engineering experience OR High school diploma/GED with 12 years of Engineering experience.

  • Bachelor's degree in Chemical or Mechanical Engineering.

  • 6+ years' relevant work experience, with 5+ years in Biopharmaceutical operations/manufacturing environments.

  • Demonstrated expertise in GMP Biopharmaceutical Production facility equipment/systems.

  • Proven analytical skills, with experience using data-driven techniques and analyses (e.g., Data Analytics, Root Cause Analysis (RCA), Statistical Process Control (SPC), Six Sigma, Predictive Maintenance).