MFG Associate, Downstream, Swing Shift, Fremont CA

Boehringer Ingelheim•Fremont, CA

10d•Onsite

About The Position

Executes routine unit operations in Downstream manufacturing related to the production of bulk drug substance in a multi-product facility. Performs duties under limited supervision and according to standard operating and manufacturing procedures. The position includes a swing-shift schedule of Sunday through Wednesday: Sunday through Tuesday, 3:00 PM to 1:30 AM PST (overnight into the next day); Wednesday, 3:00 PM to 11:30 AM PST. The employee must work according to schedules within a 24/7 shift structure and be flexible to adapt their schedule with prior notice. The role performs a range of manufacturing, testing, documentation, equipment, and area-support activities in a highly regulated environment. Work is conducted under applicable site procedures and cGMP, EHS, and compliance policies. The employee contributes to product quality, safe operations, team performance, and the company's discovery, development, and delivery of products.

Requirements

High school degree and at least one year of work experience in a GMP-regulated industry, or an associate's/bachelor's degree from an accredited institution or biotechnology vocational training (the latter credentials or training are preferred).
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.
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.
Ability to work assigned schedules in a 24/7 shift structure and adapt the schedule with prior notice.
Follow applicable company and site procedures and policies for cGMP, EHS, and compliance.

Nice To Haves

Associate's 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).
Basic knowledge of fundamental manufacturing concepts.

Responsibilities

Execute complex unit operations under the 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.
Prepare buffers and transfer them into tanks and disposables.
Perform in-process testing, including spectrophotometry, pH, and conductivity, and maintain analytical equipment.
Perform supporting duties such as parts cleaning, weighing and dispensing, stocking consumables and materials, updating controlled SOP binders, and disposing of expired reagents appropriately.
Recognize and report process and equipment anomalies.
Document work according to cGMP and cGDP requirements.
Follow applicable regulations and site-established cGMP procedures.
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 current and, after qualifying as a trainer, train other technicians and associates on operations.
Contribute to Quality activities, including investigations and area walk-throughs.