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- Fremont, CA 94537
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Master Manufacturing Associate, Downstream - Days
Boehringer Ingelheim • Fremont, CA
Posted 12 days ago
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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. Serves as an operations subject matter expert (SME) representing the department during audits, new product introductions, and technical assessments.
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\:
Independently executes complex unit operations including but not limited to chromatography operations, tangential flow filtration, various filtration methods, and process monitoring. Supports equipment and process troubleshooting and implements continuous improvement projects of low to moderate complexity in the production areas. Defines user requirements for new equipment and validation protocols.
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. Conducts group trainings on complex topics and scientific principles as needed.
Contributes to Quality activities as investigations and area walk-throughs.
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.
Subject Matter Expert of biopharmaceutical manufacturing practices, as well as a high technical knowledge of biologics principles 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.
Must be legally authorized to work in the United States without restriction.
Must be willing to take a drug test and post-offer physical (if required)
Must be 18 years of age or older
Boehringer Ingelheim is one of the world’s top 20 pharmaceutical companies and operates globally with approximately 50,000 employees. Since our founding in 1885, the company has remained family-owned and today we are committed to creating value through innovation in three business areas including human pharmaceuticals, animal health and biopharmaceutical contract manufacturing. Since we are privately held, we have the ability to take an innovative, long-term view. Our focus is on scientific discoveries and the introduction of truly novel medicines that improve lives and provide valuable services and support to patients and their families. Employees are challenged to take initiative and achieve outstanding results. Ultimately, our culture and drive allows us to maintain one of the highest levels of excellence in our industry. We are also deeply committed to our communities and our employees create and engage in programs that strengthen the neighborhoods where we live and work. Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Animal Health USA, Merial Barceloneta, LLC and Boehringer Ingelheim Fremont, Inc. is an equal opportunity and affirmative action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender identity or expression; affectional or sexual orientation; disability; veteran or military status, including protected veteran status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
Boehringer Ingelheim is firmly committed to ensuring a safe, healthy, productive and efficient work environment for our employees, partners and customers. As part of that commitment, Boehringer Ingelheim conducts pre-employment verifications and drug screenings.