This list contains only the countries for which job offers have been published in the selected language (e.g., in the French version, only job offers written in French are displayed, and in the English version, only those in English).
With minimal supervision, support the execution of manufacturing/quality systems such as non-conformances, process validation, procedures, training, and new product introductions. Apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations. May serve as primary production process owner for process support systems and assist with process ownership responsibilities on more complex process systems.
Job Responsibility:
Initiate, revise, and approve manufacturing procedures
Assess process performance and implement solutions for process improvement
Provide troubleshooting support
Assist in generation of training materials
Support establishment of process monitoring parameters and control limits
Ensure that all Non-conformances are triaged within the established goal
Author investigation reports
Execute corrective actions
Manage NC/CAPA closure
Monitor and communicate incidents trends
Review equipment/system Root Cause Analysis investigations
Assist with generation and execution of process validation protocols and reports
May participate in regulatory inspections
Participate in the NPI process
Assess, prioritize, justify, and provide implementation and project management support for process or equipment modification projects
Assist manufacturing change owner on CCRB packages
Participate on the assessment or implementation of special projects or initiatives
Requirements:
Doctorate degree OR Master's degree and 3 years of Manufacturing Operations experience OR Bachelor's degree and 5 years of Manufacturing Operations experience OR Associate’s degree and 10 years of Manufacturing Operations experience OR High school diploma / GED and 12 years of Manufacturing Operations experience
Detailed technical understanding of bioprocessing unit operations
Skilled in performance of GMP production operations
Regulatory knowledge and interactions
Ability to communicate and collaborate with technical and management staff within manufacturing, process development, and quality
Organizational, technical writing and presentation skills
Basic project management skills
Basic knowledge of control charting
Nice to have:
Bachelor's in Science or Engineering is preferred
Manufacturing Experience
Hands on experience managing CAPA & Change Controls