Aseptic Manufacturing Specialist

Planet Pharma; Thousand Oaks (CA); Vor Ort; USD 34.000 - 48.000; Vollzeit

Zusammenfassung

Planet Pharma in Thousand Oaks, CA is seeking a technically skilled aseptic processing resource to support 24/7 drug product manufacturing. You will help drive continuous improvements, revise SOPs and work instructions, and own aseptic deviations as the 24/7 transition approaches in 2027.

The role begins with a Monday–Friday schedule, then shifts to a Wed–Sun schedule to cover the 24/7 operation needs. Strong data interpretation and process optimization focus are essential.

Qualifikationen

• Aseptic processing knowledge and attention to compliance.
• Ability to interpret data and support continuous improvement initiatives.
• Experience revising controlled documents like SOPs and work instructions.
• Capability to own aseptic deviations and resolve issues.

Aufgaben

• Serve as an aseptic processing technical resource supporting 24/7 drug product manufacturing.
• Initially M-F 8-5, transitioning to Wed-Sun 8-5 once 24/7 operations begin in 2027.
• Support continuous improvement initiatives to strengthen aseptic compliance, process robustness, and efficiency.
• Revise SOPs, work instructions, and related records to reflect process changes and improvements.
• Own aseptic-related deviations and drive corrective actions.
• Support evaluation of 1+ year of aseptic call log data to identify trends, root causes, and improvements.
• Develop clear metrics, summaries, and outputs that translate operational data into decisions and next steps.
• Maintain a cyclic process for information gathering, challenges, improvements, and effectiveness assessment.

Jobbeschreibung

Planet Pharma in Thousand Oaks, CA is seeking a technically skilled aseptic processing resource to support 24/7 drug product manufacturing. You will help drive continuous improvements, revise SOPs and work instructions, and own aseptic deviations as the 24/7 transition approaches in 2027.

The role begins with a Monday–Friday schedule, then shifts to a Wed–Sun schedule to cover the 24/7 operation needs. Strong data interpretation and process optimization focus are essential.