Senior Manufacturing Specialist

📋 Description

• Ensure operational efficiency and compliance by managing technical documentation, addressing
• Streamline processes and drive continuous improvement across manufacturing operations.
• Effective change management, thereby fostering process enhancements and ensuring compliance with
• Conduct technical writing and collaborate with Operations and cross-functional team to investigate
• Develop and implement corrective and preventive measures together with the Operations team and
• Manage change processes to enhance operations.

🎯 Requirements

• Master or Degree with at least 5-7 years relevant experience in Biologics Production facility, or
• Good working knowledge of cGMP and regulatory requirements related to Manufacturing is preferred.
• Strong working knowledge of GMP systems such as Trackwise, SAP, LIMS, MES systems are preferred.
• Experience with cGMP documentation and record maintenance.
• Experience with Regulatory inspections is required.
• Strong ability to lead and drive cross-functional teams.

🎁 Benefits

• Equal Opportunity Employer/Veterans/Disabled.