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

Boehringer Ingelheim•Fremont, CA

11d•$65,400 - $113,400•Onsite

About The Position

Executes routine Downstream manufacturing unit operations related to bulk drug substance manufacturing in a multi-product facility. Work is performed under limited supervision and according to standard operating and manufacturing procedures. The role contributes to the discovery, development, and delivery of products and offers opportunities to collaborate internationally. The scheduled day shift is Wednesday through Saturday, 0600–1630. The position also requires working according to schedules in a 24/7 shift structure and adapting the work schedule with prior notice. The role may be eligible for a role-specific discretionary bonus, relocation assistance, and/or other compensation elements. The stated base salary range is $65,400–$98,000 or $75,600–$113,400. 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.

Requirements

High school degree and at least two years of work experience in a GMP-regulated industry for the Senior level; high school degree and at least four years for the Master level.
At least two years of cGMP-regulated industry experience for the Senior level; at least four years for the Master level.
Ability to concentrate on detail-oriented work in a complex technical setting, with a Quality and right-the-first-time mindset.
Strong written and verbal communication skills.
Ability to use computer-based systems; experience with process control systems such as Delta V and manufacturing execution systems (MES) is desirable.
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 the Master level, strong working knowledge of biopharmaceutical manufacturing practices and a strong understanding of biologics principles are required.
For the Senior level, strong working knowledge of fundamental manufacturing concepts is required.
Work in a highly regulated environment while following applicable BI and BI Fremont SOPs, OCPs, and BGSs for cGMP, EHS, and Compliance policies.
Work according to schedules in a 24/7 shift structure and adapt the work schedule with prior notice.

Nice To Haves

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

Responsibilities

Execute complex unit operations with oversight of qualified staff, including chromatography, tangential flow filtration, filtration methods, and process monitoring.
Independently perform fundamental operations after adequate training, including CIP/SIP of tanks, transfer lines, and process equipment; buffer preparation and transfer; and in-process testing such as spectrophotometry, pH, and conductivity.
Maintain analytical equipment.
Perform parts cleaning and weigh-and-dispense activities as needed.
Stock consumables and materials, update controlled SOP binders, discard expired reagents appropriately, and recognize and report process or equipment anomalies.
Document work in accordance with cGMP and cGDP.
Follow applicable regulations and site-established cGMP requirements.
Report abnormalities and deviations in a timely and accurate manner.
Follow safety standards, identify unsafe situations or habits, and escalate them appropriately.
Maintain production areas according to predefined 5S standards.
Keep personal training compliant and train other technicians and associates on operations after qualifying as a trainer.
Contribute to Quality activities, including investigations and area walk-throughs.