Senior Technician, Biological Production

BoehringerPRD; Gainesville (GA); On-site; USD 60,000 - 90,000; Full time

Job summary

Boerhinger Ingelheim is seeking a Senior Technician, Biological Production to support vaccine production on-site in the United States. The role involves leading aseptic processes, operating production equipment, and performing MES/SAP transactions in line with cGMP requirements.

You will mentor less experienced technicians, conduct on-the-job training, and ensure documentation and regulatory standards are met. The position requires a degree in a related science and relevant GMP experience.

Qualifications

• Bachelor's degree in Biology, Biochemistry, Biotechnology, Microbiology, Chemical Engineering, Bioengineering, or related scientific discipline with 1+ year production in a cGMP environment.
• OR Associate's degree with 3+ years of production/related experience in a cGMP environment.
• OR High school diploma with 5+ years production experience in a cGMP environment, plus demonstrated technical competence and quality mindset.

Responsibilities

• Leads aseptic processes, weighing, measuring, counting, calculations, sampling, and verifications for biological production per cGMP and safety standards.
• Oversees operation of production equipment and ensures release of materials for use.
• Performs MES and system transactions in support of production output.
• Conducts MES exception acknowledgement and time confirmations in SAP and investigates inventory discrepancies.
• Performs in-process batch quality checks, cleaning, and environmental monitoring.
• Provides direction and mentoring to less experienced Technicians and Operators.

Skills

Technical troubleshooting

Documentation accuracy

Safety compliance

Mentoring

Education

Bachelor's degree in Biology/Biochemistry/Biotechnology/Microbiology/Chemical Engineering/Bioengineering

Associate's degree in related science with 3+ years GMP experience

High school diploma with 5+ years GMP production experience

Tools

SAP

MES

Job description

Description

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 an opportunity for all employees to collaborate internationally, offering visibility and the opportunity to directly contribute to the company's success. We realize that our strength and competitive advantage lie with our people. We support our employees in several 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.

The Senior Technician, Biological Production is responsible for the setup, operations, and troubleshooting of equipment in the production areas in support of the biological products produced at the site(s). This role is responsible for required production process documentation, MES and systems functions and oversight. The incumbent must integrate quality control, safety, and business process excellence into work practices.

The SR Technician, Biological Production supports vaccine production in accordance with all product specifications and current cGMP standards. This role provides direction and mentoring to less experienced Technicians and Operators in the areas of production processes, procedures, and equipment set up.

Duties & Responsibilities

• - Leads aseptic processes, weighing, measuring, counting, calculations, sampling, 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.
• - Performs MES and system transactions/functions in support of biological production output.
• - Independently performs MES exception acknowledgement and time confirmations in SAP, with the ability to investigate and properly address inventory discrepancies.
• - Performs equipment, process, and procedure troubleshooting/review.
• - Independently performs in-process batch quality checks, cleaning, environmental monitoring, and other relevant production processes in accordance with procedures.
• - Supports safety activities within the area.
• - Independently troubleshoots production equipment and process problems, document findings, and implement solutions to resolve problems.
• - Provides recommendations and assists in the investigation of process deviations.
• - Participate in an on-call rotation and respond to after-hours escalations accordingly and as needed to maintain safe, compliant, and continuous operations.
• - Performs batch record reviews as defined by Management for completed production items.
• - Creates and/or conducts reviews of relevant SOPs, Controlled Forms and other business function documents to support regulatory compliance and change controls.
• - 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 required.
• OR
• - 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 required.
• OR
• - 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 required.
• - 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.
• - Ability to participate in an on-call schedule and respond within the timeframe established by the business to ensure safe, compliant, and continuous operations.
• - On call and call in compensation will be administered in accordance with company policy.

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.

Desired Skills, Experience and Abilities