As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

Responsible for the set up, operations, and troubleshooting of equipment in the production areas in support of the biological products produced at the site(s). Responsible for required production process documentation, MES and systems functions and oversight. Must integrate quality control, safety, and business process excellence into work practices. Supports vaccine production in accordance with all product specifications and current cGMP standards. Provides direction and mentoring to less experienced Technicians and Operators in the areas of production processes, procedures, and equipment set up.

Duties & Responsibilities

• Executes aseptic processes in the production labs, including cell and bacterial culture inoculations and passaging, sampling, disinfection, and environmental monitoring of those processes. Performs calculations and verifications required for biological production processes in accordance with cGMP, safety standards, and established production documentation and procedures.
• Oversees operation of production equipment and ensures all equipment, instruments and production materials are released and available for use. Coordinates equipment orders and inventory movements necessary to execute production schedules. Performs MES and system transactions/functions in support of biological production output. Independently performs MES exception acknowledgements and time confirmations in SAP, with the ability to investigate and properly address inventory discrepancies.
• Independently performs all necessary in-process batch quality checks and in-process testing, including microbiological evaluations for purity and yield, preparation of serial dilutions and cell counting, and other relevant production processes in accordance with established procedures. Monitors bacterial and cell/viral cultures through SCADA and other available digital systems.
• Independently troubleshoots production equipment and process problems, documents findings, and implement solutions to resolve problems. Provides recommendations and assists in the investigation of process deviations. Assists Scientists in the performance of protocols and microbiological process evaluations and data analysis.
• Performs batch record reviews as defined by Management for completed production processes. Creates and/or conducts reviews of relevant SOPs, Controlled Forms and other business function documents to support regulatory compliance and change control processes.
• Generates recommendations and executes on new or updated workplace practices and processes. Creates and/or modifies production procedures, reports, and records as needed.
• Leads by example. Provides direction and mentoring to less experienced Technicians and Operators in the areas of production processes, procedures, and equipment set up.
• Responsible for process training as Qualified Trainer. Independently performs OJT (On Job Training) final assessments as directed by Department Management.

Requirements

• Bachelor's Degree in Biology, Biochemistry, Biotechnology, Microbiology, Chemical Engineering, Bioengineering, or related scientific discipline a minimum of one (1) year production, operations or related experience in a cGMP, pharmaceutical, bio-production, manufacturing or similar environment.
• In lieu of relevant bachelor's degree, incumbent must have an Associate's Degree in Biology, Biochemistry, Biotechnology, Microbiology, Chemical Engineering, Bioengineering, or related scientific discipline/relevant trade school and three (3) years of production, operations or related experience in a cGMP, pharmaceutical, bio-production, manufacturing or similar environment, or a high school diploma/GED and a minimum of five (5) years production, operations or related experience in a cGMP, pharmaceutical, bio-production, manufacturing or similar environment.
• Additionally, demonstrated Technical Competence, Communication, Delivering Results, Time Management, Initiative and Quality Mindset.
• Candidates must complete the Technician Certification through Boehringer Ingelheim's training program within 12 months of accepting the role or must have successfully completed the certification prior to accepting the position.

Eligibility Requirements:

• 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