Biopharma Facilities Engineer - 4x10 Weekend Shift

Infotree Global Solutions; Thousand Oaks (CA); Vor Ort; USD 90.000 - 130.000; Vollzeit

Zusammenfassung

Infotree Global Solutions is seeking an Engineer to join Client Thousand Oaks' Facilities & Engineering team. The role focuses on biopharmaceutical process equipment, system ownership, and continuous improvement in a regulated environment.

The position involves 4x10-hour shifts with weekend coverage, heavy emphasis on troubleshooting, commissioning, qualification, and risk mitigation to ensure reliable operations across fill lines, CIP, autoclaves, and related systems.

Qualifikationen

• Bachelor’s degree in Chemical or Mechanical Engineering.
• 4+ years' of relevant work experience with 2+ years' experience in Biopharmaceutical operations/manufacturing environment.
• Experience in regulated environments (e.g. cGMP, OSHA, EPA) and familiarity with GMP quality systems/processes.
• Knowledge of GMP Biopharmaceutical Production facility equipment/systems (e.g., continuous fill lines, CIP, autoclaves, lyophilization).
• Ability to analyze problems and propose engineering solutions using data-driven methods (RCA, SPC, Six Sigma).
• Experience applying engineering principles to system modifications and capital projects.

Aufgaben

• Provide system ownership for Biopharmaceutical process equipment and lead improvements.
• Coordinate equipment maintenance to ensure peak capacity.
• Ensure commissioning and qualification of systems with inspectors as needed.
• Monitor systems to identify performance risks and implement risk reduction strategies.
• Lead/root cause analysis and implement corrective/preventive actions.
• Support new product/technology introductions by engineering assessments and equipment modifications.
• Align regional medical activities with SOPs.

Kenntnisse

GMP knowledge

Root Cause Analysis

Process equipment troubleshooting

Data-driven decision making

Capital project execution

Ausbildung

Bachelor’s degree in Chemical or Mechanical Engineering

Jobbeschreibung

Infotree Global Solutions is seeking an Engineer to join Client Thousand Oaks' Facilities & Engineering team. The role focuses on biopharmaceutical process equipment, system ownership, and continuous improvement in a regulated environment.

The position involves 4x10-hour shifts with weekend coverage, heavy emphasis on troubleshooting, commissioning, qualification, and risk mitigation to ensure reliable operations across fill lines, CIP, autoclaves, and related systems.