Senior Technician, Biological Production

Boehringer Ingelheim•Gainesville, FL

12d

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 production process documentation and MES and system functions, integrating quality control, safety, and business process excellence into work practices. The technician supports vaccine production in accordance with product specifications and current cGMP standards, and provides direction and mentoring to less experienced Technicians and Operators. The position includes participation in an on-call rotation and responding to after-hours escalations as needed to maintain safe, compliant, and continuous operations.

Requirements

Bachelor's degree in Biology, Biochemistry, Biotechnology, Microbiology, Chemical Engineering, Bioengineering, or a related scientific discipline, plus at least one year of production, operations, or related experience in a cGMP, pharmaceutical, bio-production, manufacturing, or similar environment; OR
Associate's degree in a listed or related scientific discipline, or relevant trade school, plus three years of production, operations, or related experience in a cGMP, pharmaceutical, bio-production, manufacturing, or similar environment; OR
High school diploma or GED plus at least five years of production, operations, or related experience in a cGMP, pharmaceutical, bio-production, manufacturing, or similar environment.
Demonstrated technical competence, communication, delivering results, time management, initiative, and quality mindset.
Complete Boehringer Ingelheim's Technician Certification training 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.
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 at least 18 years of age.

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 supporting 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 within the production area.
Troubleshoot production equipment and process problems, document findings, and implement solutions.
Recommend actions and assist with investigations of process deviations.
Participate in an on-call rotation and respond to after-hours escalations as needed.
Perform batch record reviews for completed production items as directed by Management.
Create and/or review SOPs, Controlled Forms, and other business documents to support regulatory compliance and change controls.
Recommend and implement new or updated workplace practices and processes.
Create or modify production procedures, reports, and records as needed.
Lead by example and mentor less experienced Technicians and Operators on production processes, procedures, and equipment setup.
Provide process training as a Qualified Trainer.
Independently perform OJT final assessments as directed by Department Management.