Boehringer Ingelheim Mfg Associate, Sr. Associate OR Master Associate - Downstream in FREMONT, California

Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment which benefits our employees, patients and communities.

The qualified candidate will be hired at theappropriate level commensurate with education/experience.

Associate and Sr.Associate Description:

Executes 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 ofqualified staff, complex unit operations including but not limited tochromatography operations, tangential flow filtration, various filtrationmethods, and process monitoring.

  • Executes independently withadequate training fundamental operations:

  • CIP/SIP of tanks, transferlines, and process equipment.

  • Buffer preparation andtransfer into tanks and disposables.

  • Performs In process testingfor samples e.g. spectrophotometry, pH, conductivity, and maintenance ofanalytical equipment.

  • This may include parts cleaningand weigh and dispense.

  • Performs internal supportduties including stocking consumables/materials, updating controlled SOPbinders, appropriately discarding expired reagents, recognizing andreporting process and equipment anomalies.

  • Documents work according tocGMP and cGDP.

  • Adheres to establishedregulations and follows cGMP established by site.

  • Reports abnormalities anddeviations in a timely and accurate manner.

  • Adheres to safety standards andidentifies unsafe situations / habits and escalates appropriately.

  • Maintains production areasaccording to predefined standards (5s).

  • Maintains own training withincompliance and trains other technicians and associates on operations uponcompletion of trainer qualification.

  • Contributes to Qualityactivities as investigations and area walk-throughs.

Associate Requirements:

  • High school degree plus minimumone (1) year work experience in GMP regulated industry

  • Associates/Bachelor’s degreefrom an accredited institution or biotechnology vocational trainingpreferred.

  • One (1) or more years ofexperience in cGMP regulated industry.

  • Ability to concentrate ondetail oriented work in a complex technical setup with a Quality and Rightthe first time mindset.

  • Strong written and verbalcommunication skills.

  • Ability to work withcomputer-based systems and ideally experience with process control systems(e.g. Delta V) and manufacturing execution systems (MES).

  • Ability to read and understandSOPs and work instructions and document work in a written format applyingcGMP standards.

  • Ability to work as part of ahigh performing team and collaborate effectively with staff.

  • Basic knowledge of fundamentalmanufacturing concepts is preferred. Does not require extensive technicalknowledge of manufacturing operations.

  • Working in a highly regulatedenvironment following all applicable BI and BI Fremont SOPs, OCPs and BGSsfor cGMP, EHS and Compliance policies.

  • Required to work according togiven schedules in a 24/7 shift structure and flexibility to adapt workingschedule upon prior given notice.

Sr. Associate Requirements:

  • High school degree plus minimumtwo (2) year’s work experience in GMP regulated industry

  • Associates/Bachelor’s degreefrom an accredited institution or biotechnology vocational trainingpreferred.

  • Two (2) or more years ofexperience in cGMP regulated industry.

  • Ability to concentrate ondetail oriented work in a complex technical setup with a Quality and Rightthe first time mindset.

  • Strong written and verbalcommunication skills.

  • Ability to work withcomputer-based systems and ideally experience with process control systems(e.g. Delta V) and manufacturing execution systems (MES).

  • Ability to read and understandSOPs and work instructions and document work in a written format applyingcGMP standards.

  • Ability to work as part of ahigh performing team and collaborate effectively with staff.

  • Strong working knowledge offundamental manufacturing concepts is required. Moderate technicalknowledge of biologics operations is preferred.

  • Working in a highly regulatedenvironment following all applicable BI and BI Fremont SOPs, OCPs and BGSsfor cGMP, EHS and Compliance policies.

  • Required to work according togiven schedules in a 24/7 shift structure and flexibility to adapt workingschedule upon prior given notice.

Master Associate 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. 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 complexunit operations including but not limited to chromatography operations,tangential flow filtration, various filtration methods, and processmonitoring. Supports equipment and process troubleshooting and implementscontinuous improvement projects of low to moderate complexity in theproduction areas. Defines user requirements for new equipment andvalidation protocols.

  • Executes independently withadequate training fundamental operations:

  • -CIP/SIP of tanks, transferlines, and process equipment.

  • -Buffer preparation andtransfer into tanks and disposables.

  • -Performs In process testingfor samples e.g. spectrophotometry, pH, conductivity, and maintenance ofanalytical equipment.

  • This may include parts cleaningand weigh and dispense.

  • Performs internal supportduties including stocking consumables/materials, updating controlled SOPbinders, appropriately discarding expired reagents, recognizing andreporting process and equipment anomalies.

  • Documents work according tocGMP and cGDP.

  • Adheres to establishedregulations and follows cGMP established by site.

  • Reports abnormalities anddeviations in a timely and accurate manner.

  • Adheres to safety standards andidentifies unsafe situations / habits and escalates appropriately.

  • Maintains production areasaccording to predefined standards (5s).

  • Maintains own training withincompliance and trains other technicians and associates on operations uponcompletion of trainer qualification. Conducts group trainings on complextopics and scientific principles as needed.

  • Contributes to Qualityactivities as investigations and area walk-throughs.

Master Associate Requirements:

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

  • Associates/Bachelor’s degreefrom an accredited institution or biotechnology vocational trainingpreferred.

  • Four (4) or more years ofexperience in cGMP regulated industry.

  • Ability to concentrate ondetail oriented work in a complex technical setup with a Quality and Rightthe first time mindset.

  • Strong written and verbalcommunication skills.

  • Ability to work withcomputer-based systems and ideally experience with process control systems(e.g. Delta V) and manufacturing execution systems (MES).

  • Ability to read and understandSOPs and work instructions and document work in a written format applyingcGMP standards.

  • Ability to work as part of ahigh performing team and collaborate effectively with staff.

  • Subject Matter Expert ofbiopharmaceutical manufacturing practices, as well as a high technicalknowledge of biologics principles required.

  • Working in a highly regulatedenvironment following all applicable BI and BI Fremont SOPs, OCPs and BGSsfor cGMP, EHS and Compliance policies.

  • Required to work according togiven schedules in a 24/7 shift structure and flexibility to adapt workingschedule upon prior given notice.

Eligibility Requirements:

  • Must be legally authorized towork in the United States without restriction.

  • Must be willing to take a drugtest and post-offer physical (if required)

  • Must be 18 years of age orolder

Our Culture:

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.

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Organization: US-BI Fremont

Title: Mfg Associate, Sr. Associate OR Master Associate - Downstream

Location: Americas-US-CA-Fremont

Requisition ID: 1813416