Senior Technician, Biological Production

Boehringer Ingelheim•Gainesville, GA

33d

About The Position

The Senior Technician, Biological Production is responsible for setting up, operating, and troubleshooting equipment in production areas supporting biological products. The role handles required production process documentation, MES and system functions, and oversight, while integrating quality control, safety, and business process excellence into work practices. The Senior Technician supports vaccine production in accordance with product specifications and current cGMP standards, and provides direction and mentoring to less experienced Technicians and Operators on production processes, procedures, and equipment setup. The role also supports safe, compliant, and continuous operations through equipment and process troubleshooting, production documentation and batch record reviews, process deviation investigations, safety activities, and participation in an on-call rotation. The Senior Technician serves as a Qualified Trainer and performs on-the-job training final assessments as directed by Department Management.

Requirements

Bachelor's degree in Biology, Biochemistry, Biotechnology, Microbiology, Chemical Engineering, Bioengineering, or a related scientific discipline and at least one year of production, operations, or related experience in a cGMP, pharmaceutical, bio-production, manufacturing, or similar environment; alternatively, an associate's degree in one of these fields or relevant trade school and three years of such experience; or a high school diploma/GED and five years of such experience.
Candidates without the specified degree must demonstrate Technical Competence, Communication, Delivering Results, Time Management, Initiative, and a Quality Mindset.
Complete Boehringer Ingelheim's Technician Certification through its training program within 12 months of accepting the role, or have successfully completed the certification before accepting the position.
Ability to participate in an on-call schedule and respond within the timeframe established by the business to ensure safe, compliant, and continuous operations.
Must be legally authorized to work in the United States without restriction.
Must be willing to take a drug test and post-offer physical, if required.
Must be 18 years of age or older.

Responsibilities

Lead aseptic processes, weighing, measuring, counting, calculations, sampling, and verifications for biological production in accordance with cGMP, safety standards, and established documentation and procedures.
Oversee production equipment operation and ensure equipment, instruments, and production materials are released and available for use.
Perform MES and system transactions and functions in support of biological production output.
Independently perform MES exception acknowledgements and SAP time confirmations, investigate inventory discrepancies, and address them appropriately.
Troubleshoot and review equipment, processes, and procedures.
Independently perform in-process batch quality checks, cleaning, environmental monitoring, and other relevant production processes according to procedures.
Support safety activities in the production area.
Independently troubleshoot production equipment and process problems, document findings, and implement solutions.
Recommend and assist with investigations of process deviations.
Participate in an on-call rotation and respond to after-hours escalations as needed to maintain safe, compliant, and continuous operations.
Perform batch record reviews for completed production items as defined by Management.
Create and/or review SOPs, Controlled Forms, and other business documents to support regulatory compliance and change controls.
Recommend and execute new or updated workplace practices and processes.
Create and/or modify production procedures, reports, and records as needed.
Lead by example and provide direction and mentoring to less experienced Technicians and Operators on production processes, procedures, and equipment setup.
Provide process training as a Qualified Trainer.
Independently perform on-the-job training final assessments as directed by Department Management.