Sr Manufacturing Associate, Upstream, ONSITE, Fremont CA

Boehringer Ingelheim GmbH; Fremont, Northern (CA, KY); Hybrid; USD 75,000 - 122,000; Full time

Job summary

Boehringer Ingelheim in Fremont, CA seeks a Sr Manufacturing Associate for Upstream operations onsite. The role executes unit operations, monitors processes, and supports continuous improvement in a multi-product biopharma facility.

The shift is Wed–Sat, 8:00 pm–6:30 am PST. Requires GMP experience; high school diploma with 2+ years in GMP; associates or bachelor's preferred; opportunity to contribute to QA, cGMP adherence, and 5S in a dynamic team.

Qualifications

• High school diploma plus 2 years in GMP industry.
• Associate's or Bachelor's degree preferred.
• 2+ years of experience in cGMP environment.
• Detail-oriented with a quality mindset.
• Strong written and verbal communication skills.
• Experience with DeltaV and MES systems.
• Able to read SOPs/work instructions and document accordingly.
• Team player capable of collaborating in a high performing group.
• Background in biologics manufacturing operations preferred.

Responsibilities

• Execute complex unit operations including batching and inoculation of bioreactors, operation, process monitoring and harvest.
• Support equipment troubleshooting and continuous improvement projects of low complexity.
• Perform CIP/SIP, media prep, transfer into tanks and disposables, cell inoculation.
• Maintain daily analytics and equipment upkeep; document work per cGMP and site SOPs.
• Stock consumables, update SOP binders, discard expired reagents, report anomalies.
• Maintain 5S production areas and participate in QA investigations and walks.

Skills

Attention to detail

Communication skills

cGMP knowledge

DeltaV experience

MES experience

Education

Associate's or Bachelor's degree

High school diploma

Biotechnology vocational training

Tools

DeltaV

MES

Job description

Sr Manufacturing Associate, Upstream, ONSITE, Fremont CA

Description

Executes and coordinates unit operations in Upstream manufacturing as assigned related to the manufacturing of bulk drug substance in a multi-product facility. Performs duties under limited supervision and according to standard operating and manufacturing procedures. 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 a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

The shift for this role is: Wed - Sat, 8:00pm - 6:30am PST

Duties & Responsibilities

• Independently executes complex unit operations including, but not limited to, batching and inoculation of bioreactors, operation of bioreactors, process monitoring, and harvest operations. May contribute to equipment and process troubleshooting, as needed. Implements continuous improvement projects of low complexity in the production areas.
• Executes independently with adequate training fundamental operations:
  • CIP/SIP of bioreactors, tanks, and harvest equipment.
  • Media preparation and transfer into tanks and disposables.
  • Cell inoculation and transfer.
  • Daily analytics and maintenance of analytical equipment.
• May be required to support parts cleaning and weigh and dispense operations.
• Performs internal support duties including stocking consumables/materials, updating controlled SOP binders, appropriately discarding expired reagents, recognizing and reporting process and equipment anomalies.
• 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 as investigations and area walk-throughs.

Requirements

• High school degree plus minimum two (2) year’s work experience in GMP regulated industry
• Associates/Bachelor’s 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. Delta V) 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.
• Requires moderate to high technical knowledge of biologics manufacturing operations.
• Working in a highly regulated environment following all applicable BI and BI Fremont SOPs, OCPs and BGSs for cGMP, EHS and Compliance policies.
• Required to work according to given schedules in a 24/7 shift structure and flexibility to adapt working schedule upon prior given notice.

The base salary range for this position is $75,000 to $122,000. The position may be eligible for a role specific discretionary bonus, relocation, and/or other compensation elements. We continuously review market data and may adjust salary ranges as needed in the future. Actual compensation will be based on job-related factors such as skills, experience, and qualifications, and other factors permitted by law. For an overview of our benefits please click here .