Senior Technician, Biological Production

Boehringer Ingelheim; Gainesville (GA); Vor Ort; USD 70.000 - 110.000; Vollzeit

Zusammenfassung

Boehringer Ingelheim Pharmaceuticals, Inc. is seeking a Senior Technician, Biological Production at our Georgia site.

The role involves setup, operation, and troubleshooting of production equipment, MES and SAP transactions, and mentoring junior technicians to maintain compliant, safe operations. The incumbent will perform batch reviews, support SOP and procedure updates, and contribute to continuous improvements while participating in on-call rotations to ensure continuous production and

Qualifikationen

• Bachelor's degree in Biology, Biochemistry, Biotechnology, Microbiology, Chemical Engineering, Bioengineering or related field plus 1 year cGMP production experience.
• Or an Associate's degree plus 3 years of production experience in a cGMP environment.
• Or high school diploma with 5 years of production experience in a cGMP environment and demonstrated core competencies.
• Candidates must complete the Technician Certification within 12 months or have prior certification.
• Ability to participate in an on-call schedule and respond within required timeframes.

Aufgaben

• Lead aseptic processes and verifications for biological production.
• Oversee production equipment operation and material readiness.
• Perform MES and SAP transactions and investigate inventory discrepancies.
• Conduct in-process batch quality checks and environmental monitoring.
• Mentor and train junior technicians and operators.
• Participate in on-call rotations and after-hours escalations as needed.

Kenntnisse

Mentoring

On-call readiness

Troubleshooting

Documentation

Ausbildung

Bachelor's degree in biology / related field

Associate's degree + 3 years cGMP experience

High school diploma + 5 years cGMP experience

Tools

SAP

MES

SOPs

Jobbeschreibung

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