Section Leader, Manufacturing

AVEVA DRUG DELIVERY SYSTEMS INC•Miramar, FL

22h•Onsite

About The Position

Assists Supervisor and provides daily leadership to employees in the Manufacturing department to ensure safety and quality, maximizing productivity and efficiency while fostering a positive work environment. Plans and communicates daily production needs within the team. Coordinates, trains, mentors, and leads the blending, coating/drying/laminating (CDL) and Finishing operators for Aveva’s transdermal and transmucosal products. Leads manufacturing teams on all assigned job duties, communicating overtime needs, training of new hires, and helping R&D with new processes as Subject Matter Expert. Keeps the supervisor informed of all issues that occur on the shift. Carries out responsibilities in accordance with the organization’s policies, procedures, and state, federal, and local laws. 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.

Requirements

High school diploma or general education degree (GED).
10+ years' experience in a fast-paced lean Manufacturing/Packaging (pharmaceutical manufacturing, food manufacturing) in a GMP environment required.
Demonstrate career progression within Aveva with a minimum of 3 years' experience as a Back-up Section Leader, or equivalent related experience.
Demonstrates thorough leadership, coaching skills, manufacturing expertise, safety measures knowledge, time management, organizational skills, and the ability to motivate workers.
Understands, adheres to, practices Current Good Manufacturing Practices (cGMPs) and to observe safety, environmental, and security policies and procedures during the performance of all assigned responsibilities.
Computer knowledge (e.g. JDE, Web Navigation, Email, MS Word and MS Excel).
Ability to read English and comprehend documents such as policies, Standard Operating Procedures, batch records and cleaning procedures.
Ability to write in English, and complete batch record documentation.
Ability to speak English effectively.
Must be able to use basic mathematical calculations in multi-level/complex formulas using whole numbers, common fractions, and decimals, following rounding and significant figure rules.
Ability to apply common sense understanding to carry out detailed written and oral instructions.
Ability to apply problem solving technics to address problems involving variables in standardized situations.
Ability to gather data/facts and assists with GMP investigations.

Nice To Haves

Transdermal Manufacturing/ Packaging experience preferred.

Responsibilities

Carries out responsibilities in accordance with the organization’s policies, procedures, and state, federal, and local laws.
Leads, Trains, mentors, and leads blending, coating/drying/laminating (CDL) and Finishing operations staff in blending operations and assists in the training of Blender Operator I staff throughout all other manufacturing operations.
Restocks supply rooms and cleans blending and manufacturing facilities.
Coordinates all manufacturing crews in their daily activities.
Assemble and disassemble all blending and manufacturing equipment.
Ensures Operators monitor and document the critical process parameters during the manufacturing process.
Investigates process problems, notifies Supervisors, and takes appropriate corrective actions.
Performs batch processing steps in accordance with Batch Record manufacturing instructions and current labor standards in order to safely and efficiently manufacture a quality product.
Verifies the correctness of all raw materials against the appropriate issuance documents to ensure that the correct materials are used during the manufacturing process.
Knowledge of blending room control panel functionality including but not limited to temperature controllers and chart laminate.
Work with active drug products, adhesives, solvents and various other chemicals to perform all steps in the manufacturing process.
Wear appropriate personal protective equipment for blending or manufacturing tasks being performed.
Weigh and document the weights of raw materials, components, and product intermediaries.
Provide input and evaluate revisions and the creation of blending batch records.
Maintain all blending and kettle storage rooms in a clean and organized manner.
Aid R&D with trial, scale-up and clinical blend batches.
Document manufacturing steps performed in the coating/drying/laminating (CDL) and Finishing batch records and perform batch record accountability records.
Document operational parameters for manufacturing equipment and provide input in the creation of all manufacturing batch records.
Help maintain the blending, coating/drying/laminating (CDL) and Finishing parts inventory and perform on-line coat weight sampling operations.
Prepare finished or slit laminate rolls.
Maintain and clean manufacturing and production areas and equipment.
Document work performed in appropriate logbooks.
Perform on-line coat weight and sampling operations.
Perform other 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.
Ensures housekeeping standards are followed and area is maintained during shift.
Ensures area housekeeping / 5s initiatives are sustained, and all other relevant duties as assigned.