Manufacturing Operator
Aveva Drug Delivery Systems, Florida, NY, United States
Job Summary
Assists in the manufacturing of Aveva’s transdermal and transmucosal products (coating, drying, laminating and finishing). Assists in other manufacturing processes for Aveva’s products when manufacturing activities are complete.
Job 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 tests 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.
Job Requirements
Education : High school diploma or general education degree (GED)
Experience : Minimum of 1 year of related experience and/or training in Manufacturing/Packaging (pharmaceutical manufacturing, food manufacturing) in a GMP environment required; or equivalent.
Knowledge, Skills and Abilities :
Must be able to perform each essential job function satisfactorily.
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 understanding 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.
Physical Requirements and Working Conditions
While performing the duties of this job, the employee is regularly required to sit, stand and walk. The employee is frequently required to use hand to finger, handle or feel; reach with hands and arms; and talk and hear. The employee is occasionally required to stoop, kneel, crouch or crawl. The employee must frequently lift and/or move up to 50 pounds. The employee is regularly exposed to moving mechanical parts. The employee is frequently exposed to fumes or airborne particles and toxic caustic chemicals. The noise level in the work area is usually loud. The employee will be required at times to wear a full‑face respirator and/or TYVEK or TYCHEM jumpsuits during cleaning operations, as well as eye protection, hearing protection and other personal protective equipment (PPE) as required. The employee may be required to work additional hours from time to time, including weekends. Shift hours are subject to change due to operational needs.
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Assists in the manufacturing of Aveva’s transdermal and transmucosal products (coating, drying, laminating and finishing). Assists in other manufacturing processes for Aveva’s products when manufacturing activities are complete.
Job 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 tests 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.
Job Requirements
Education : High school diploma or general education degree (GED)
Experience : Minimum of 1 year of related experience and/or training in Manufacturing/Packaging (pharmaceutical manufacturing, food manufacturing) in a GMP environment required; or equivalent.
Knowledge, Skills and Abilities :
Must be able to perform each essential job function satisfactorily.
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 understanding 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.
Physical Requirements and Working Conditions
While performing the duties of this job, the employee is regularly required to sit, stand and walk. The employee is frequently required to use hand to finger, handle or feel; reach with hands and arms; and talk and hear. The employee is occasionally required to stoop, kneel, crouch or crawl. The employee must frequently lift and/or move up to 50 pounds. The employee is regularly exposed to moving mechanical parts. The employee is frequently exposed to fumes or airborne particles and toxic caustic chemicals. The noise level in the work area is usually loud. The employee will be required at times to wear a full‑face respirator and/or TYVEK or TYCHEM jumpsuits during cleaning operations, as well as eye protection, hearing protection and other personal protective equipment (PPE) as required. The employee may be required to work additional hours from time to time, including weekends. Shift hours are subject to change due to operational needs.
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