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BPI Labs, LLC

Senior Machine Operator

BPI Labs, LLC, Largo, Florida, United States, 34640

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Join a team that’s driving innovation, integrity, and impact across the pharmaceutical industry. Senior Machine Operator Date Posted:

December 12, 2025

Job Type:

Full Time

Job Summary: We seek a skilled, detail-oriented individual looking for a rewarding career in sterile‑injectable manufacturing. The Senior Machine Operator role involves operating and monitoring fully automated robotic aseptic filling machines and packaging inspection machines for vials, prefilled syringes (PFS), and cartridges, ensuring strict adherence to quality control protocols and maintaining a clean and organized work environment.

Responsibilities:

Performs all assigned duties in compliance with current Good Manufacturing Practices (cGMPs), following BPI Labs’ Quality Manual and Facility Standard Operating Procedures (SOPs).

Sterile fill robots and inspection packaging machines setup, operation, qualification/validation, maintenance and automation/software validation.

Follows gowning and personnel hygiene practices while doing duties.

Records all pertinent operations in logbooks and controlled documents.

Reports to team leader/supervisor any issues/problems that might affect quality, etc.

Completes in a timely manner the training curriculum and all work‑related training for the position.

Formulation/manufacturing, filtration/purification, sampling and in‑process testing of sterile drug products, and operation, calibration, maintenance of inspection and packaging machines using various equipment/instruments.

Mixing equipment such as magnetic drive mixers setup, operation and maintenance.

Support formulation scientist in process/drug development.

Performs labeling and packaging of injection products.

Visually inspects injections for particulates under inspection light hoods as per Standard Operating Procedures.

Perform experimental design, proven acceptable range studies, determine critical process parameters and control them to produce consistent quality drug product.

Sterilization of process equipment, filters, tubing, utensils, components and their qualification by performing head distribution/heat penetration, biological indicator challenging studies with the help of experienced validation engineers and microbiologists.

Cleans and maintains production equipment and environments.

Assists engineers with batch records and batch record requests.

Assists with leading a team of technicians during agreed upon shift.

Ability to work 1st and 2nd shift and weekends as needed.

Performs additional related duties as assigned.

Qualifications:

3+ years in a manufacturing environment, preferably in the pharmaceutical industry.

High School diploma required; college degree in engineering or a similar field preferred.

Strong mechanical aptitude.

401(k)

Health insurance

Paid time off

Vision insurance

Work Location: Largo, FL

12393 Belcher Rd S. Suite 450 Largo, FL 33773

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