MFG Senior/Master, Downstream, Fremont CA, Day Shift

Boehringer Ingelheim GmbH; Fremont (CA); On-site; USD 65,000 - 113,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

Retirement savings

Paid time off

Paid holidays

Disability & life insurance

Job summary

Boehringer Ingelheim Fremont is seeking a MFG Senior/Master, Downstream for Day Shift in Fremont, CA. Executes routine unit operations in downstream manufacturing of bulk drug substance in a multi-product facility, under limited supervision in compliance with cGMP.

Responsibilities include chromatography operations, tangential flow filtration, CIP/SIP, buffer prep, in-process testing, and maintaining equipment.

Qualifications

• High school degree plus minimum four (4) years work experience in GMP regulated industry.
• Associates/Bachelors degree from an accredited institution preferred.
• Four (4) or more years of experience in cGMP regulated industry.

Responsibilities

• Executes complex unit operations including chromatography, tangential flow filtration, and filtration methods.
• Performs CIP/SIP, buffer prep and transfer into tanks and disposables.
• Performs in-process testing (spectrophotometry, pH, conductivity) and maintains equipment.
• Documents work per cGMP and reports anomalies; adheres to safety and 5S standards.
• Maintains training and supports quality investigations and area walks.

Skills

Chromatography

Tangential flow filtration

CIP/SIP

Analytical testing

DeltaV MES experience

Detail oriented

Team collaboration

Education

High school degree + 4 yrs GMP

Associates/Bachelors preferred

Tools

DeltaV

MES systems

Job description

MFG Senior/Master, Downstream, Fremont CA, Day Shift

The base salary range for this position is $65,400 to $98,000 OR $75,600 to $113,400. The position may be eligible for a role-specific discretionary bonus, relocation assistance, 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, qualifications, and other factors permitted by law. Benefits include medical, dental, and vision coverage, retirement savings opportunities, paid time off, paid holidays, disability and life insurance benefits, and other company-sponsored benefits. For additional information regarding our benefits and Total Rewards offerings, please click here .

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, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees

Day Shift: Wed-Sat 0600-1630

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.

MFG Master Requirements

• High school degree plus minimum four (4) years work experience in GMP regulated industry
• Associates/Bachelors 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.

MFG Senior Requirements

• High school degree plus minimum two (2) year's work experience in GMP regulated industry
• Associates/Bachelors 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.