Sr Manufacturing Associate, Upstream, ONSITE, Fremont CA

Boehringer Ingelheim; Fremont (CA); On-site; USD 75,000 - 122,000; Full time

Job summary

Boehringer Ingelheim Fremont is seeking a Upstream Technician to execute unit operations in a multi-product biopharma facility. You will work in a 24/7 shift, performing bioreactor operations, media prep, and cell inoculation with strict cGMP adherence.

The role requires GMP experience, strong documentation, and teamwork in a regulated setting. Competitive compensation and opportunities for growth are offered at the Fremont site.

Qualifications

• High school degree plus 2+ years in GMP regulated industry.
• Associates or Bachelor’s degree in biotechnology or related field preferred.
• 2+ years of experience in a cGMP regulated industry.

Responsibilities

• Independently executes complex unit operations including batching and bioreactor inoculation, monitoring and harvest operations.
• Performs CIP/SIP, media preparation, and cell inoculation with adequate training.
• Maintains documentation according to cGMP and adheres to safety standards.

Skills

Bioreactor operations

CIP/SIP

Media preparation

Cell inoculation

Analytical equipment handling

Process monitoring

Team collaboration

Documentation

Education

Associates/Bachelor's degree in biotechnology

Tools

DeltaV

MES

Process control systems

Job description

Executes and coordinates 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.

The shift for this role is: Wed - Sat, 8:00pm - 6:30am PST

Duties & Responsibilities

• Independently executes complex unit operations including, but not limited to, batching and inoculation of bioreactors, operation of bioreactors, process monitoring, and harvest operations. May contribute to equipment and process troubleshooting, as needed. Implements continuous improvement projects of low complexity in the production areas.
• 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 two (2) year's work experience in GMP regulated industry
• Associates/Bachelor's degree from an accredited institution or biotechnology vocational training preferred
• 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
• Requires moderate to high technical knowledge of biologics 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 Details

The base salary range for this position is $75,000 to $122,000. 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.

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