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Job Description
Bioprocess Associate Job Description
Seeking a detail-oriented Bioprocess Associate to maintain a safety-oriented, cGMP compliant work environment, assist in facility and equipment start-up and validation, and execute production operations.
About Wu Xi Biologics Ireland
Wu Xi Biologics Ireland is a world-class provider of biologics services, encompassing every stage from discovery through to commercialization, serving global clients in the biopharmaceutical and healthcare industries.
Key Responsibilities:
- Assist in maintaining a safety-oriented, cGMP compliant work environment.
- Support Facility and Equipment start-up and Validation activities as needed.
- Provide input on equipment installation, start-up, operation, and troubleshooting for new product introduction.
- Assist the Production team in meeting output targets and quality levels on schedule.
- Execute all production operations as per SOPs and Manufacturing Batch Records.
- Perform initial troubleshooting during routine operations.
- Participate in process investigations and optimizations using scientific, engineering, and lean principles.
- Train and mentor colleagues in SOPs, process execution, and equipment operation.
- Write, review, and revise SOPs, Batch Records, Logbooks, Training Competencies, and Work Instructions.
- Notify the Shift Lead or Senior Team Member of any SOP deviations or production process issues.
- Perform housekeeping duties to maintain high facility standards.
- Complete and maintain all assigned training for full compliance.
- Ensure the highest Quality & Compliance standards.
- Be flexible in taking on additional tasks and responsibilities as directed by the Manufacturing Shift Lead.
- Function as a role model in adherence to Wu Xi corporate core values and PROUD culture.
Requirements:
- Certificate, Diploma, Degree, or equivalent in Science, Engineering, or a related field is advantageous.
- 0-3 years experience in biopharmaceutical or pharmaceutical cGMP manufacturing.
- Thorough knowledge of current Good Manufacturing Practices (GMP) is required.
- Knowledge of biotech manufacturing processes and their translation into documentation such as batch records and SOPs is advantageous.
Personal Skills:
- Excellent communication, interpersonal, and presentation skills.
- Collaborative and inclusive approach to work and colleagues.
- Excellent problem-solving and troubleshooting skills.
- Flexible approach to work and a positive attitude that fits well within the team dynamic.
- Ability to engage cross-functionally in conjunction with a site-based team.
- Autonomous and a self-starter who uses initiative to drive actions forward.
Benefits:
- Bonus
- educational assistance
- Sports & Social Club
- VHI