What are the responsibilities and job description for the Engineering/Manufacturing Operator position at Aurobindo Pharma USA, Inc.?
Division Overview
Aurolife was founded in 2008 as part of a group of companies that has a long history of excelling in generic pharmaceutical prouct development and manufacturing. Aurolife has a 10 year history of extraordinary manufacturing practices in the solid oral dose arena. The support and expertise of our parent organization has given Aurolife a jump start in building a solid pharmaceutical portfolio very quickly. The Aurolife family consists of an experienced management team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In addition to several formulations under manufacture, we have a robust pipeline of products. Aurolife's aim is to provide healthcare at economical prices to make this a healthier world to live in.
Job Overview
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
Responsibilities
WAREHOUSE OR PRODUCTION POSITION – While performing the duties of this job the employee is required to: Regularly lift and/or move objects 10-50lbs Frequently required to stand, walk, stoop, kneel, crouch or crawl Occasionally required to sit and climb or balance Specific vision abilities required for this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust and focus The worker is subject to environmental conditions. Protection from weather conditions but not necessarily from temperature changes The worker is subject to both environmental conditions. Activities occur inside and outside Medium work Exerting up to 50 pounds of force occasionally, and/or up to 30 pounds of force frequently, and/or up to 10 pounds of force constantly to move objects.
Additional
Physical Requirements
No Additional Requirements
Blood/Fluid Exposure Risk
Category III: Tasks involve no exposure to blood, body fluids or tissues. Category I tasks are not a condition of employment.,
Aurolife was founded in 2008 as part of a group of companies that has a long history of excelling in generic pharmaceutical prouct development and manufacturing. Aurolife has a 10 year history of extraordinary manufacturing practices in the solid oral dose arena. The support and expertise of our parent organization has given Aurolife a jump start in building a solid pharmaceutical portfolio very quickly. The Aurolife family consists of an experienced management team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In addition to several formulations under manufacture, we have a robust pipeline of products. Aurolife's aim is to provide healthcare at economical prices to make this a healthier world to live in.
Job Overview
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
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.
- 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.
- experience with topical and inhalation product manufactruring is a plus
WAREHOUSE OR PRODUCTION POSITION – While performing the duties of this job the employee is required to: Regularly lift and/or move objects 10-50lbs Frequently required to stand, walk, stoop, kneel, crouch or crawl Occasionally required to sit and climb or balance Specific vision abilities required for this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust and focus The worker is subject to environmental conditions. Protection from weather conditions but not necessarily from temperature changes The worker is subject to both environmental conditions. Activities occur inside and outside Medium work Exerting up to 50 pounds of force occasionally, and/or up to 30 pounds of force frequently, and/or up to 10 pounds of force constantly to move objects.
Additional
Physical Requirements
No Additional Requirements
Blood/Fluid Exposure Risk
Category III: Tasks involve no exposure to blood, body fluids or tissues. Category I tasks are not a condition of employment.,
- 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.
- 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.