Production Operations Operator - Night Shift - 5pm-5am

Lannett Company•Seymour, IN

18h

About The Position

Performs functions related to processing drug products in accordance with current Good Manufacturing Practices (cGMP), customer requirements, and Standard Operating Procedures (SOPs). The operator is responsible for safely and efficiently completing assigned work while ensuring products meet established standards. This role operates equipment used to manufacture and package oral solid dose products. The position includes documenting batch records and logbooks, performing and recording in-process quality checks, cleaning and operating production and packaging equipment, completing changeovers, and maintaining production reports. Operators collaborate with teammates, communicate issues to supervisors, assist with on-the-job training, and help identify and implement continuous improvement opportunities. Other related duties may be assigned to support departmental and company objectives.

Requirements

High school diploma or GED.
Ability to work various hours and shifts, including weekends when necessary.
Knowledge of metric and English weighing and measurement systems.
Basic understanding of mechanical machinery and control-system operating principles.
Demonstrated mathematical ability in addition, subtraction, multiplication, division, ratios, and percentages.
Ability to use a calculator and computer systems, including Word, Excel, SAP, Outlook, SharePoint, Master Control, and Success Factors.
Ability to follow verbal and written instructions, including SOPs and batch-record documentation.
Accuracy and precision when recording data and batch information.
English reading and writing proficiency sufficient to understand work instructions and document results.
Ability to operate pharmaceutical processing equipment and meet cGMP standards.
Understanding of unit operations and ability to assist with on-the-job training of manufacturing trainees and operators.
Ability to complete visual inspections and maintain accountability.
Ability to meet the described equipment-operation competencies across assigned production areas, including dispensing, granulation, encapsulation, compression, coating, fluid-bed processing, and printing/laser-drill/inspection.
Ability to perform the physical activities described, including standing, walking, sitting, climbing, balancing, stooping or crouching, kneeling, reaching, pulling, pushing, grasping, talking, and hearing.
Ability to work near moving mechanical parts and electrical current and to be exposed to chemicals.
Visual abilities including clarity of vision at 20 feet or more and 20 inches or less, judging distance and spatial relationships, focusing sharply, and seeing up, down, right, and left while fixed on a point.
Ability to identify and distinguish colors.
Ability to exert force continuously, frequently, occasionally, or rarely as described, including moving objects with a hand truck.
Ability to wear respiratory protection, including air-purifying respirators and supplied-air respirators.

Nice To Haves

0–2 years of production or packaging experience is an asset.
Strong background in solid-dose manufacturing or packaging is preferred.

Responsibilities

Complete batch records and logbooks accurately and in detail.
Perform required in-process product quality checks and document the results.
Follow procedures to complete work safely and efficiently.
Clean pharmaceutical production and packaging equipment and facilities.
Operate pharmaceutical manufacturing and packaging machinery for processes such as dispensing, mixing, granulation, coating, encapsulation, milling, blending, compression, printing, laser-drill inspection, and related operations.
Execute equipment and production changeovers.
Maintain production and packaging reports for assigned work-unit operations.
Work collaboratively as part of a team.
Assist with on-the-job training of production trainees and operators.
Communicate issues effectively to a supervisor.
Assist in identifying and implementing continuous improvement opportunities.
Perform other related duties as assigned to meet departmental and company objectives.