We are searching for innovative, intellectually curious individuals with a general understanding of Good Manufacturing Practices (GMPs) to support routine manufacturing operations for Cell Therapy. Successful candidates must be goal-oriented and flexible, with the ability to work effectively and efficiently on a team while demonstrating safety, quality, and GMP compliance at all times.
Requirements
- Execute operations as outlined in Standard Operating Procedures (SOPs) and batch records
- Execute transactions and process in all electronic systems
- Perform all tasks in a manner consistent with the safety policies, SOPs, quality systems, and GMP requirements
- Complete training assignments to ensure the necessary technical skills and knowledge
- Train for proficiency in process systems and some supporting business systems
- Work within a controlled cleanroom environment and perform aseptic processing (as assigned; maintain manufacturing environmental conditions (Non-Viable Particulate(s) and Viable microbial levels per controlled area classification specifications) by performing area disinfection regiment as required to meet global Health Authority requirements
- Able to train new operators
- Role models and leaders for the culture of compliance
- Controlled document & Deviation authoring, change impact assessment and action owner
- Demonstrate a strong practical and theoretical knowledge in their work
- Can represent department in cross-functional department collaborations
- May before Team Lead duties as needed / delegated
- Complete documentation required by governing controlled documents and batch records
- Solve complex technical problems; takes new perspectives using existing solutions
- Train others on SOPs, Work Instructions to successfully complete manufacturing operations
Benefits
- Competitive benefits
- Services
- Programs
- Flexible work environment
- Opportunities for growth and development
- Professional and productive work environment
- Social responsibility
- Innovation culture
- Supportive work environment