Engineering/Manufacturing Operator

Aurobindo Pharma USA, Inc. • Durham, NC

25d

About The Position

Engineering /Manufacturing Operator is to perform all required Batch manufacturing, packing, equipment cleaning, area cleaning, in- process testing & sampling for Manufacturing and Packaging batches for Transdermal Products primarily and potentially Topical and Inhalation

Requirements

• Hands on experience with transdermal product manufacturing equipment is a must
• Familiar with proper documentation and correction practices.
• Read, write and speak English REQUIRED.
• Knowledge of transdermal product manufacturing machine adjustments during set up, operation, troubleshooting, cleaning before & after use.
• Knowledge of weights, scales & measures, experience of handling measuring equipment/instruments.
• Must be a team player able to effectively communicate with QA Supervisor, IPQA, Quality Control, Production, Warehouse, Engineering and Supply Chain to meet finished product release goals.
• Be able to work long hours to support production requirements with flexibility to rotate 1st, 2nd or 3rd shift.
• Be available for overtime, including weekends, as needed for production support.
• Possess the ability to analyze information and make consistently good decisions.
• A familiarity with cGMPS, CFRs, OSHA and FDA regulations.
• Knowledge of deviations/incidents and CAPA.
• High School Diploma with some college courses, Associates Degree.
• Up to 3 years of experience performing Batch Manufacturing and Packing, In-process checks/verifications in the Manufacturing and Packaging areas of TRANSDERMAL pharmaceuticals manufacturing environment.
• Experienced with operation & maintenance of pharmaceutical or any type of equipment/machinery.
• Certified in any engineering stream – preferred mechanical or instrumental engineering.

Nice To Haves

• experience with topical and inhalation product manufactruring is a plus

Responsibilities

• Perform maintenance and troubleshooting of transdermal equipment and machinery.
• Perform verifications using special instruments (Caliper, Balance, etc.).
• Assist the Batch manufacturing, Packing & Cleaning of the equipment machinery and area.
• Assist all required In-process testing & sampling of batches in progress and products to be packaged.
• Assist Calibration of weighing and required equipment.
• Perform packaging activities.
• Handle various requests from departments for developmental or investigative reasons.
• Complete all applicable training forms in a timely manner and forward to document control for archival.
• Perform other duties as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Associate degree
• Number of Employees: 1,001-5,000 employees