Manufacturing Project Associate Level 2

About the position

The Manufacturing Project Associate Level 2 offers an outstanding opportunity to be part of a dynamic team dedicated to delivering world-class manufacturing solutions. At Lonza, we are committed to encouraging a culture of collaboration and excellence, where every employee is empowered to contribute to our bold goals. This role is perfect for those who are passionate about manufacturing and quality, and are eager to make a significant impact.

Responsibilities

• Support Manufacturing leads in reviewing and approving process Batch Records to ensure flawless execution of production.
• Identify quality issues, involve collaborators, and drive issues to successful completion or resolution.
• Participate in Risk Assessments and own, drive, and complete Corrective and Preventive Actions (CAPA).
• Review, build, approve, and own Manufacturing documents, and review/approve commissioning documents to maintain high standards.
• Review/Approve Functional Specification (FS), Functional Design Specifications (FDS), and electronic Batch Record (eBR) Change requests to ensure regulatory compliance.
• Update Single Use Component assembly designs as needed to meet ongoing production requirements.
• Support Manufacturing Leads in Tech Transfer activities, ensuring departmental readiness for new processes.
• Review and approve documents in the Document Management System (DMS), including Work Instructions, Standard Operating Procedures (SOP), Learning Qualification Modules (LQM), and Batch Records.
• Maintain and develop technical knowledge on manufacturing equipment, Quality Control, Quality Assurance, and customer processes to ensure continuous improvement.
• Perform technical analyses on manufacturing equipment and processes using PI (Plant Information) data, batch record review, flow path analyses, and suite GEMBAs to identify areas for improvement.
• Provide training and support for the execution of new or changed manufacturing process operations.
• Assist Manufacturing leads in the implementation of analytical equipment, including purchase, installation, and integration into existing manufacturing systems, and support system administrators in validation and meeting data integrity requirements.

Requirements

• Prefer Bachelor's Degree or equivalent experience in industry-related subject, or 3-5 years proven Biotechnology, Upstream and/or Downstream, or similar manufacturing experience.
• Excellent written and verbal communication skills, with a strong emphasis on technical writing.
• Outstanding planning, time management, and coordination skills, with the ability to adapt to changes in priorities and project schedules.
• Attention to detail, strong problem-solving abilities, and excellent interpersonal skills.
• Familiarity with SAP systems is an advantage.