Associate Maintenance Engineer

Division Overview:





Aurolife was founded in 2008 as part of a group of companies that has a long history of excelling in generic pharmaceutical product 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 give 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:


The Associate Maintenance Engineer works in the field and onsite with facilities management, HVAC, process equipment and utilities and manages all respective documentation.





Responsibilities:


Preparation, review and approval of engineering drawings.





Handling of quality management software.





Planning and execution of equipment and Utility IQ/OQ qualifications





Planning and preparation of engineering Standard Operating Procedures and risk assessments.





Coordinate with cross functionality teams to initiate and close Change Controls, CAPA’s and deviations.





Assist maintenance team with implementation of new tools, systems, and technologies to drive operational efficiency.





Assist the engineering manager with preparing requests for proposals for new equipment and projects





Assist the maintenance team to deploy software tools and techniques to enhance compliance





Assist the projects team in preparing cost estimates





Follow the laid down Quality Culture Principles and Behaviors





Preparation of master equipment list.





Preparation and finalization of preventive maintenance checklist and schedules.





Preparation of master calibration list and calibration schedules.





Ensure the execution of preventive maintenance and calibration schedules with internal or external sources.





Review and verification of all calibration certification details and their archival





Issuance, execution and archival of all approved documents on timely basis as per respective SOPs.





Preparation, Review and Effectiveness of SOP in DMS.





Train staff memebers on SOPs belonging to respective departments by preparing question banks, initiating a self-study course or offline course or external training in Nichelon.





Review the logbooks related to utilities, Facility and executed documents.





Adhere to safety, good documentation and Good Manufacturing Practices.





Practice/implement good Engineering practices.





Follow quality and culture principles and behaviors.





Qualifications - Skills & Requirements:


Must be detail oriented to ensure that all action items in QAMS related to Change Control, CAPAs, and deviations are attended to and thoroughly closed according to action plans.





Education & Experience:


Bachelor of Science degree in Mechanical, or Electrical Engineering or related studies required.





Physical Requirements:


FIELD - While performing the duties of this job the employee is required to: •Work in a temperature controlled office environment or travel via vehicle or commercial transportation •While performing the duties of this job, the employee is occasionally required to handle or feel objects, talk, hear, and walk during the course of employment •Position requires some degree of travel for business purposes •Employee may use computer, phone, copier and other office equipment in the course of a day •Specific vision abilities required by the job include close vision, distance vision, vision, peripheral vision, depth perception and an ability to adjust focus Sedentary work Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.





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.





We Are An Equal Opportunity Employer:


Aurobindo Pharma USA, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to , , , , , , status, genetics, protected veteran status, , or expression, or any other characteristic protected by federal, state or local laws.





This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.