Master/Sr Manufacturing Associate, Upstream, ONSITE, Fremont CA- Night Shift (Fremont, CA, United States, California)

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.

Master MFG Associate Requirements

High school degree plus minimum four (4) year’s work experience in GMP regulated industry

Associates/Bachelor’s degree from an accredited institution or biotechnology vocational training preferred.

Four (4) 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.

Strong working knowledge of biopharmaceutical manufacturing practices, as well as a strong understanding of biologics principles are required.

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.

Senior MFG Associte 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.

Compensation Details

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 .

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