Manufacturing Operator

AVEVA DRUG DELIVERY SYSTEMS INC•Miramar, FL

18h•Onsite

About The Position

Assists in the manufacturing of Aveva’s transdermal and transmucosal products, specifically involving coating, drying, laminating, and finishing processes. The role also includes assisting in other manufacturing processes once primary activities are complete. Key responsibilities involve manufacturing coating, drying, laminating, and finishing batches with active drug substances consistently, coating blends and adhesives to produce laminate, and preparing finished and slit laminate rolls. The operator is required to strictly follow all Batch Record and SOP instructions, complete all necessary documentation, and perform on-line coat weight sampling and other in-process tests as specified. This position also entails performing batch record accountability calculations, weighing, and documenting raw materials, components, and product intermediates. Compliance with current Good Manufacturing Practices (cGMPs), Standard Operating Procedures (SOPs), and safety policies is paramount. The role includes maintaining and cleaning manufacturing and production areas and equipment according to SOPs, and working with active drug products, adhesives, solvents, and various other chemicals. The operator will perform tasks across production and other departments as needed, working collaboratively within a team. All operations must adhere to the company's Code of Conduct and Business Ethics, and all established regulatory, compliance, and safety requirements, supporting the corporate values of Innovate, Evolve, and Excel.

Requirements

High school diploma or general education degree (GED)
Minimum of 1 year of related experience and/or training in Manufacturing/Packaging (pharmaceutical manufacturing, food manufacturing) in a GMP environment required; or equivalent combination of education and experience.
Ability to read English and interpret documents such as safety rules, Standard Operating Procedures batch records and cleaning procedures.
Ability to write in English and complete batch record documentation.
Ability to speak English effectively.
Ability to add, subtract, multiply and divide in 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 understating to carry out detailed written and oral instructions.
General mechanical ability to assemble manufacturing equipment.
Knowledge of FDA, DEA, cGMPs, and SOPs related to job requirements.

Responsibilities

Manufactures coating, drying, laminating and finishing batches of blend batches with active drug substances on a consistent basis.
Coats blends and adhesives to produce laminate.
Prepares finished and slit laminate rolls.
Follows all Batch Record and SOP instructions and completes all relevant documentation as required.
Documents operational parameters and steps performed in the batch record.
Performs on-line coat weight sampling operations and other in-process test as required by the batch record.
Performs batch record accountability calculations.
Weighs and documents the weights of raw materials, components and product intermediates as required.
Complies 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 per SOP requirements.
Works with active drug products, adhesives, solvents and various other chemicals to accomplish the tasks listed above.
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 corporate values: Innovate, Evolve and Excel.
All other relevant duties as assigned.