FAQs
What is the main focus of this position?
The main focus of this position is to provide day-to-day operations support for the Aseptic Filling Operations, specifically the Visual Inspection and Packaging Processes.
What kind of experience is required for this position?
The ideal candidate should have relevant bio/pharmaceutical experience in aseptic manufacturing operations, with a Bachelor's degree in Engineering, Pharmaceutical Sciences, or a related technical field.
What are some of the responsibilities of this role?
Responsibilities include providing technical expertise and support for Inspection and Packaging operations, troubleshooting process issues, conducting root cause analysis, participating in process validation activities, and supporting regulatory inspections.
What skills are necessary for this role?
Skills needed include strong knowledge of cGMP regulations and quality systems, experience with visual inspection systems and packaging processes in a cGMP environment, proficiency in data analysis and statistical tools, detail-oriented with strong analytical and problem-solving skills, and effective communication and collaboration abilities.
Are there any preferred qualifications for this position?
Preferred qualifications include experience with qualification and validation protocols, familiarity with Lean Six Sigma principles and continuous improvement methodologies.