Description

Executes and coordinates unit operations in Downstream 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, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees

This shift will be Monday-Friday, Day Shift.

*In the new year days will change to Sunday-Wednesday 4X10

Duties & Responsibilities

Independently executes complex unit operations including but not limited to chromatography operations, tangential flow filtration, various filtration methods, and process monitoring. 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 tanks, transfer lines, and process equipment.
- Buffer preparation and transfer into tanks and disposables.
- Performs In process testing for samples e.g. spectrophotometry, pH, conductivity, and maintenance of analytical equipment.
May contribute to equipment and process troubleshooting, as needed. Implements continuous improvement projects of low complexity in the production areas.
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.

Manufacturing Senior Associate Requirements

High school degree plus minimum two (2) years' work experience in GMP regulated industry
Associates/Bachelor's 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 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 fundamental manufacturing concepts is required. Moderate technical knowledge of biologics operations is preferred.
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.

Manufacturing Associate 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.
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 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 fundamental manufacturing concepts is required. Moderate technical knowledge of biologics operations is preferred.
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 Data

This position offers a base salary typically between (41,000) and (80,000). 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.