Packaging Operator

About Us:
Aveva Drug Delivery Systems is a pharmaceutical manufacturer at the forefront of innovative drug delivery technologies. We are dedicated to advancing solutions that optimize the efficacy, safety, and precision of pharmaceutical treatments. Join our team and help shape the future of healthcare by contributing to the development of groundbreaking drug delivery systems that improve patient outcomes worldwide.

Job Summary 

Level I Packaging Operators may be assigned to specific tasks within the following general range of duties and responsibilities based on the specific training and qualifications they have achieved. Training of Level I Packaging Operators is performed to qualify each operator in all the specific duties and responsibilities applicable to each Packaging Line, on a line-by-line basis. Following this strategy, Operators become fully qualified for every Operator's responsibility on individual lines and may successively be trained on operating every line.

Key Responsibilities  

• Packaging Operators follow Batch Record instructions that specify materials, components, labeling, and processing parameters to be utilized, in-process sampling, testing, and inspection, etc. Packaging Operators document the work performed as specified in the Batch Record.
• During packaging operations, Packaging Operators are responsible for monitoring the operation of the equipment, the processing parameters utilized, and the product produced.
• Based on inspection and monitoring activities and feedback from downstream manufacturing staff and On-Line QC, the Packaging Operator adjusts as required or specified in Batch Records, performs clearance of machine jams, troubleshoots minor production problems, and makes minor adjustments for processing parameters, etc.
• After each run, the Packaging Operator shuts down the line or prepares for lot change as directed in Batch Records and required by the Production Schedule.
• Packaging Operators perform product counts, initiate Line Clearance and/or Cleaning Procedures, confirm satisfactory completion and recording of line clearances, equipment and area cleaning, post status and in-process product/lot number labeling, and complete all associated documentation as specified in Batch Records and SOPs.
• Packaging Operators maintain Packaging Lines in a clean and orderly state. Performs minor and spot cleaning as required.
• Provides QA Support for Audits and Inspections.
• Verifies documentation and reports for accuracy.
• Comply with all aspects of quality management systems, cGMP policies, documentation, and record-keeping per industry and FDA standards. Enforce safety and sanitation regulations.

Education:

• Associate degree or High School Diploma or equivalent as well as good handwriting and basic data entry and mathematical skills.

Experience:

• Two years of experience in Food/OTC or other FDA Regulated production environments preferred.

Knowledge, Skills and Abilities

• Must have legible handwriting, and the ability to perform accurate documentation.
• Must be able to count accurately, and have good basic math skills such as adding, subtracting, multiplying, and dividing.
• Must be organized, capable of following instructions, and have the ability to ability to coordinate multiple activities simultaneously.
• Must be able to work in a methodical and organized fashion and maintain mental focus to ensure efficient and accurate completion of individual tasks.
• Must be mechanically oriented and understand the function and operation of common tools and the operation of PLCs and graphical user interfaces on equipment.
• Must be familiar with functions of equipment systems that operate utilizing multiple utilities such as compressed air, electrical supply, vacuum, steam, chilled water, etc.
• Must have basic computer skills including data entry.

Benefits:

• Aveva Drug Delivery Systems and DifGen Pharmaceuticals provides a comprehensive benefits plan
• Medical/Dental/Vision Insurance
• Paid Time Off
• 401k with employer match
• Paid Holidays and Floating Holiday

Equal Opportunity Employer