MFG Associate OR Senior Associate, Upstream, ONSITE, Fremont CA, SWING SHIFT

Boehringer Ingelheim; Fremont (CA); On-site; USD 54,000 - 98,000; Full time

Job summary

Boehringer Ingelheim is seeking a technician to perform routine upstream unit operations in a multi-product bioreactor facility in Fremont, CA, with a swing shift (Wed 3pm–11:30pm, Thu–Sat 3pm–1:30am) and a strong emphasis on cGMP, safety and quality.

You will execute CIP/SIP, media preparation, cell inoculation and daily analytics, document work in batch records, and support stock, SOP updates and area cleanliness.

Qualifications

• High school diploma with 1+ year GMP experience.
• Associates or Bachelor's degree preferred.
• Strong attention to detail and written/verbal communication.

Responsibilities

• Perform unit operations including bioreactor batching and inoculation under supervision.
• CIP/SIP and media preparation, cell inoculation and daily analytics.
• Document work and maintain cGMP compliance.
• Stock supplies and support SOP updates.
• Report deviations and safety issues promptly.
• Maintain production areas and 5S standards.

Skills

Detail-oriented

Communication skills

Teamwork

GMP experience

Education

High school diploma

Associates/Bachelor’s degree

Tools

DeltaV

MES

Job description

Executes routine unit operations in Upstream 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.

This is a swing shift Position: Wednesday 3pm - 11:30pm, Thursday - Saturday 3pm - 1:30am.

Description

Executes routine unit operations in Upstream 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.

Duties & Responsibilities

• Executes, with oversight of qualified staff, complex unit operations including but not limited to batching and inoculation of bioreactors, operation of bioreactors, process monitoring, and harvest operations
• Executes independently with adequate training fundamental operations:
  • CIP/SIP of bioreactors, tanks, and harvest equipment
  • Media preparation and transfer into tanks and disposables
  • Cell inoculation and transfer
  • Daily analytics and maintenance of analytical equipment
• May be required to support parts cleaning and weigh and dispense operations
• 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

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 Data

The base salary range for this position is $53,600 to $80,400 OR $65,400 to $98,000. The position may be eligible for a role specific discretionary bonus, relocation, 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, and qualifications, and other factors permitted by law. For an overview of our benefits please click here .

Our Company

Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry's top investors in research and development, the company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. Our approximately 54,300 employees serve over 130 markets to build a healthier and more sustainable tomorrow. Learn more at www.boehringer-ingelheim.com.

Why Boehringer Ingelheim?

With us, you can develop your own path in a company with a culture that knows our differences are our strengths - and break new ground in the drive to make millions of lives better.

Here, your development is our priority. Supporting you to build a career as part of a workplace that is independent, authentic and bold, while tackling challenging work in a respectful and friendly environment where everyone is valued and welcomed.

Alongside, you have access to programs and groups that ensure your health and wellbeing are looked after - as we make major investments to drive global accessibility to healthcare. By being part of a team that is constantly innovating, you'll be helping to transform lives for generations.

Want to learn more? Visit https://www.boehringer-ingelheim.com