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Boehringer Ingelheim is Hiring a MFG Associate/Sr Associate, Downstream, Fremont CA, Day Shift Near Fremont, CA
DescriptionExecutes routine 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 Duties & Responsibilities
Executes, with oversight of qualified staff, complex unit operations including but not limited to chromatography operations, tangential flow filtration, various filtration methods, and process monitoring
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
This may include parts cleaning and weigh and dispense
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
Sr 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
Associate Requirements
High school degree plus minimum one (1) year work experience in GMP regulated industry
Associates/Bachelor’s 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 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
Basic knowledge of fundamental manufacturing concepts is preferred. Does not require extensive technical knowledge of 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 DataThis position offers a base salary typically between (44,000) and (84,000). 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.