Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there?s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that?s the kind of work we want to be part of.
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.
Job Description:
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.
Qualifications:
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.
If you are passionate about manufacturing and quality, and are ready to take on an exciting and fulfilling role, we encourage you to apply!
Every day, Lonza?s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.
Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.
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