Senior/Associate, Assembly & Packaging, Fremont CA, Swing Shift

Description

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. The Associate Assembly and Packaging executes routine unit operations in Manufacturing Assembly and Packaging as assigned related to the manufacturing of drug product in a multi-product facility. This role performs duties under limited supervision and according to standard operating and manufacturing procedures.

This role is for Swing Shift Monday-Friday 2pm – 1030pm

Duties & Responsibilities

• Executes with oversight of qualified staff, complex unit operations including but not limited to equipment changeover/set-up/operation, assembly/blistering/carton packaging of pre-filled syringes and fully auto-injector device, material movement/transfer, BioMES/SAP transaction and documentation.
• Executes independently with adequate training fundamental operations: Logistic coordination, Batch record execution, Equipment use log, Work order initiation and tracking, Support creation/maintenance of defect kits, Updating controlled SOP binders, support projects.
• Documents work according to cGMP and cGDP.
• Adheres to established regulations and follows cGMP established by site.
• Reports abnormalities and deviations in a timely and accurate manner.
• Adheres to safety standards and identifies unsafe situations / habits and escalates appropriately.
• Maintains production areas according to predefined standards (5s).
• Maintains own training within compliance and trains other technicians and associates on operations upon completion of trainer qualification.
• Contributes to Quality activities such as investigations and area walk throughs.
• Responsible for performing assembly and packaging operations and assisting in visual inspection/filling operations, if required.
• Ensures components, materials and supplies are stocked prior to the start of the assembly and packaging operations.

Sr Associate Requirements

• High School degree plus minimum 2 (two) years’ work experience in GMP regulated industry.
• Associate/Bachelor degree from an accredited institution or biotechnology vocational training preferred.
• 2 or more years of experience in cGMP regulated industry.
• Ability to concentrate on detail oriented work in a complex technical setup with a Quality and Right the first time mindset.
• Strong written and verbal communication skills.
• Ability to work with computer-based systems and ideally experience with process control systems (e.g. SAP) and manufacturing execution systems (MES).
• Ability to read and understand SOPs and work instructions and document work in a written format applying cGMP standards.
• Ability to work as part of a high performing team and collaborate effectively with staff.

Requirements

• High School diploma required; Associate/Bachelor degree from an accredited institution or biotechnology vocational training preferred.
• One (1) or more years of experience in cGMP regulated industry.
• Ability to concentrate on detail-oriented work in a complex technical setup with a quality mindset.
• Strong written and verbal communication skills.
• Ability to work with computer-based systems and ideally experience with process control systems (e.g., SAP) and manufacturing execution systems (MES).
• Ability to read and understand SOPs and work instructions and document work in a written format applying cGMP standards.
• Ability to work as part of a high performing team and collaborate effectively with staff.

Compensation Data

This position offers a base salary typically between (35,000) and (56,000).  There is opportunity to consider higher compensation above this range based on business need, candidate experience and or skills.  The position may be eligible for a role specific variable or performance based bonus and or other compensation elements.  For an overview of our benefits please click here.