Blender Operator I

Aveva Drug Delivery Systems; Town of Florida (NY); On-site; USD 22,000 - 30,000; Full time

Job summary

Aveva Drug Delivery Systems is seeking a Manufacturing Operator I to join our team in New York. You will manufacture blend batches with active drug substances, coat blends and adhesives for laminate production, and assist in ensuring quality and safety standards are met throughout the process.

The role involves assembling and disassembling equipment, weighing materials, documenting batch records, and training junior operators while adhering to cGMP, FDA/DEA requirements and company safety

Qualifications

• High school diploma or GED plus a minimum of one year of related experience and/or training.
• Ability to speak English effectively.
• Ability to read, write and interpret batch records and safety procedures.
• Mechanical ability to assemble manufacturing equipment.

Responsibilities

• Manufactures blend batches with active drug substances and blends consistently.
• Leads a crew to coat blends and adhesives to produce laminate and finish coated laminate.
• Assembles and disassembles blending and manufacturing equipment.
• Weighs and documents weights of raw materials, components and intermediates.
• Documents batch record parameters and performs batch record accountability calculations.
• Assists in training Manufacturing Operator I staff.
• Works with active drug products, adhesives and solvents in the manufacturing process.
• Maintains and cleans production areas and documents work in logbooks.
• Performs on-line coat weight sampling operations.
• Operates in compliance with FDA, DEA, cGMPs and SOPs.

Skills

Speak English effectively

Write batch records

Read English documents

Mechanical ability

FDA/DEA/cGMP knowledge

Education

High school diploma or GED

Job description

Description

Job Responsibilities

Manufactures blend batches with active drug substances and blend on a consistent basis.

• Leads a crew to coat blends and adhesives to produce laminate and perform the finishing operation on coated laminate.
• Assembles and disassembles all blending and manufacturing equipment.
• Weighs and documents the weights of raw materials, components, and product intermediates.
• Documents operational parameters and steps performed in the batch record.
• Performs batch record accountability calculations.
• Assist in the training of manufacturing Operator I’s throughout all manufacturing operations.
• Works with active drug products, adhesives, solvents and various other chemicals to perform all steps in the manufacturing process.
• Documents operational parameters for manufacturing equipment.
• Complys with Current Good Manufacturing practices, Standard Operating procedures and safety policies while performing all job duties.
• Maintains and cleans manufacturing and production areas and equipment and documents work performed in appropriate logbooks.
• Performs on-line coat weight sampling operations.
• Prepares finished or slit laminate rolls.
• Performs job tasks within production and other departments as needed.
• Works as a member of a team to achieve all outcomes.
• Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements.
• Performs all work in support of our Values: Collaboration, Courage, Perseverance, and Passion.
• All other relevant duties as assigned.

Qualifications

Job Requirements

• Education
• High school diploma or general education degree (GED) plus a minimum of one year of related experience and/or training; or equivalent combination of education and experience.
• Knowledge, Skills and Abilities
• Ability to speak English effectively
• Ability to write English and complete batch record documentation.
• Ability to read, English and interpret documents such as safety rules, Standard Operating Procedures, batch records, and cleaning procedures.
• Ability to add, subtract, multiply, and divide all units of measure using whole numbers, common fractions and decimals. Ability to compute rate, ratio, percent, and to plot and interpret data graphically.
• Ability to apply common sense understanding to carry out detailed written and oral instructions.
• Mechanical ability to assemble manufacturing equipment.
• Knowledge of FDA, DEA, cGMPs, and SOPs related to job requirements