Biochemist II

Location: East Walpole
Biochemist II page is loaded## Biochemist IIremote type:
Office Based locations:
WAP Ctime type:
Full time posted on:
Posted 8 Days Agojob requisition :
R-24975

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably.
Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions.

The Biochemist II serves a key role within the Standards Manufacturing team at the Siemens Healthineers East Walpole facility. This position involves technical leadership and hands-on participation in the production of laboratory diagnostic standards and controls within a cGMP-compliant environment. The primary functions include ensuring adherence to regulatory requirements, providing technical guidance to manufacturing technicians, and acting as a Subject Matter Expert (SME) in cross-functional projects.

The role reports directly to the Senior Manager of Manufacturing-Formulation.
** Responsibilities**
* ** Quality & Compliance**:
Audit manufacturing documentation, including Manufacturing Batch Records, Bills of Materials, Routings, Process Documents, and Standard Operating Procedures (SOPs), to ensure strict cGMP compliance.
* ** Technical Leadership & Training**:
Provide technical guidance and training to manufacturing technicians, ensuring they are qualified for all manufacturing activities.
* ** Production Coordination**:
Coordinate and monitor the day-to-day work center assignments in collaboration with the Standards Manufacturing Senior Supervisor.
* ** Project Representation**:
Represent the Standards Manufacturing department in cross-functional team meetings, including design element teams, planning and scheduling, and product troubleshooting projects.
* ** Continuous Improvement**:
Identify and initiate continuous improvement activities consistent with the Healthineers Performance System (HPS) framework.
* ** Operational Support**:
Provide direct support on the manufacturing floor as needed to ensure production schedules and work center demands are met.
* ** Leadership Backup**:
May temporarily assume a supervisory role on a limited basis with direct support from the Senior Manufacturing Manager.
** Required Knowledge/Skills, Education, and Experience**
* ** Education**:
Bachelor’s degree (BS) in Medical Technology, Biology, Chemistry, Biochemistry, or a related scientific discipline.
* ** Experience**:
Minimum of five (5) years of experience in a similar role within the medical diagnostic or medical device industry.
* ** Regulatory Knowledge**:
Solid working knowledge of cGMP (Current Good Manufacturing Practices) requirements.
* ** Skills**:
Excellent organizational and time management abilities, high attention to detail, commitment to accuracy, and established critical thinking and problem-solving skills.
** Preferred Knowledge/Skills, Education, and Experience
*** Prior experience manufacturing commercialized automated immunoassays, ELISA, and/or chemiluminescent products.
* Proficiency with Microsoft Office suite applications.
* Prior knowledge and use of SAP or a similar Material Requirements Planning/Enterprise Resource Planning (MRP/ERP) system.
** Who we are**:
We are a team of more than 72,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.
** How we work:
** When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual’s potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world’s most threatening diseases and enable access to care, united by one purpose:…