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

Boehringer Ingelheim•Fremont, CA

10d•Onsite

About The Position

Executes routine unit operations in Downstream manufacturing as assigned, supporting the manufacture of bulk drug substance in a multi-product facility. Performs duties under limited supervision and in accordance with standard operating and manufacturing procedures. The role contributes to the discovery, development, and delivery of products and involves collaboration with colleagues across the company. The position is scheduled for the day shift, Wednesday through Saturday, 0600–1630. Employees are expected to work according to schedules within a 24/7 shift structure and adapt their schedules with prior notice. The compensation range is $65,400–$98,000 or $75,600–$113,400. The position may be eligible for a role-specific discretionary bonus, relocation assistance, and/or other compensation elements. Benefits include medical, dental, and vision coverage, retirement savings opportunities, paid time off, paid holidays, disability and life insurance, and other company-sponsored benefits.

Requirements

For the MFG Master level: high school degree and at least four years of work experience in a GMP-regulated industry; alternatively, the posting specifies an associate or bachelor's degree from an accredited institution or biotechnology vocational training as preferred, alongside four or more years of cGMP-regulated industry experience.
For the MFG Senior level: high school degree and at least two years of work experience in a GMP-regulated industry; alternatively, the posting specifies an associate or bachelor's degree from an accredited institution or biotechnology vocational training as preferred, alongside two or more years of cGMP-regulated industry experience.
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; process control systems such as Delta V and manufacturing execution systems (MES) experience is described as ideal.
Ability to read and understand SOPs and work instructions and document work in writing according to cGMP standards.
Ability to work as part of a high-performing team and collaborate effectively with staff.
For MFG Master: strong working knowledge of biopharmaceutical manufacturing practices and a strong understanding of biologics principles.
For MFG Senior: strong working knowledge of fundamental manufacturing concepts.

Nice To Haves

Associate or bachelor's degree from an accredited institution or biotechnology vocational training.
Experience with process control systems such as Delta V and manufacturing execution systems (MES).
For MFG Senior: moderate technical knowledge of biologics operations.

Responsibilities

Execute complex downstream unit operations with oversight of qualified staff, including chromatography, tangential flow filtration, filtration methods, and process monitoring.
Independently execute fundamental operations after adequate training, including CIP/SIP of tanks, transfer lines, and process equipment.
Prepare buffers and transfer them into tanks and disposables.
Perform in-process testing, including spectrophotometry, pH, and conductivity, and maintain analytical equipment.
Perform internal support duties, including stocking consumables and materials, updating controlled SOP binders, discarding expired reagents appropriately, and recognizing and reporting process or equipment anomalies.
Document work according to cGMP and cGDP requirements.
Follow applicable regulations and site cGMP requirements; report abnormalities and deviations accurately and promptly.
Follow safety standards, identify unsafe situations or habits, and escalate them appropriately.
Maintain production areas according to predefined 5S standards.
Keep personal training current and train other technicians and associates on operations after completing trainer qualification.
Contribute to Quality activities, including investigations and area walk-throughs.
Follow applicable site SOPs, OCPs, BGSs, cGMP, EHS, and compliance policies.