MFG Sr Associate, Filling and Visual Inspection, Fremont CA

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 Manufacturing Senior Associate, Filling and Visual Inspection executes and coordinates unit operations in Filling or Visual Inspection manufacturing as assigned related to the manufacturing of drug product in a multi-product facility. This role works under the guidance of the Manager and interacts heavily with the Master Associate.

Duties & Responsibilities

• Under general supervision, performs basic Filling or Visual Inspection operations.
• Executes continuous improvement projects of low to moderate complexity in the production areas.
• Communicates shift change information to the next shift and coordinates between other departments.
• Performs and coordinates internal support duties including stocking consumables/materials, appropriately discarding expired reagents, recognizing, and reporting process and equipment anomalies.
• Maintains production areas according to predefined standards (5s).
• Documents work according to cGMP and cGDP standards such as documenting in controlled documents (batch records, logbooks, or SOP Attachments) in accordance with SOP.
• Responsible for the real-time identification and correction of problems. Problems may include, but are not limited to mechanical issues, component issues.
• Adheres to safety standards and identifies unsafe situations / habits and escalates appropriately.
• Maintains own training within compliance and trains other technicians and associates on operations upon completion of trainer qualification.
• Participates in training new technicians on basic procedures and trouble-shooting minor process issues.
• Performs operations and demonstrate broad knowledge of processes.
• Ability to perform routine troubleshooting of support equipment/processes.
• Assesses and proposes document and processing improvements.
• Contributes to Quality activities such as investigations and area walk-throughs.
• Documents and investigates discrepancies (recognize quality issues).
• Demonstrates a proficient understanding and use of GMP systems such as BioMES, MAXIMO and LIMS.

Requirements

• High School degree plus minimum two (2) years’ work experience in GMP regulated industry.
• Associate/Bachelor degree from an accredited institution or biotechnology vocational training preferred.
• Two (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.
• 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.
• May be required to work according to given schedules and flexibility to adapt working schedule upon prior advance notice.
• Duties of this position may require the incumbent to exert some physical effort. Lifting requirements may vary depending on the manufacturing activity. Weight is typically no more than 25 pounds.
• For Visual Inspectors:
  • Must be able to read and see clearly.
  • Employment requires participating in and having acceptable result from vision testing including color blindness.

Compensation Data

This position offers a base salary typically between (60,000) and (97,000).  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.