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Manufacturing Engineer - Westbrook, United States - GTT
Description
Manufacturing EngineerContract Duration 5 Months
Job Description
The position of Manufacturing Engineer II is within our Infectious Disease Developed Markets business unit located in Scarborough, Maine.
In this role, you will be responsible for supporting product development from concept through sustained manufacturing of FDA-regulated products. Support of process development and equipment acquisition.
Experience with manufacturing processes, quality/cost savings initiatives, and implementation of engineering principles while assuring compliance with cGMP, quality, and safety standards.
This job description will be reviewed periodically and is subject to change by management.
Job Responsibilities:
The Manufacturing Engineer will be responsible for process development, equipment specification, acquisition, and implementation.
Works to identify the root cause of manufacturing failures using structured problem-solving. Applies root cause fixes to prevent reoccurrence.
Evaluates machine logic, electromechanical systems, and process controls to troubleshoot equipment.
Completes design of experiments, validation, completion of testing, and analysis of data for continuous improvement activities. Presents data to equipment teams.
Suggests and supports new methods or materials for continual improvement of quality and efficiency.
Analyzes current equipment for process suitability and provides detailed plans for improvement
Creates and revises manufacturing documents, specifications, standard operating procedures (SOPs), safety instructions, validation protocols, risk assessments, procedures and other technical documents to ensure compliant, efficient and safe procedures
Works with other engineers and technicians in developing solutions and improvements in materials, equipment, and processes as necessary
Participates in teams as necessary to ensure continual improvement, safety, and compliance
The Manufacturing Engineer will provide training and process expertise for product processing in specific areas such as process development, tooling development, and validation.
Mentors junior engineers and maintenance technicians.
Initiates and works to resolve Quality Incidents and CAPA.
Ability to travel up to 25% of the time
Basic Qualifications | Education:
Bachelor's degree (BS) in engineering or equivalent combination of education and experience.
Minimum three years of engineering experience in a manufacturing environment
Familiarity with a variety of material testing and measuring methods.
Knowledge of Database software; CAD software; Development software; Internet software; Inventory software; Manufacturing software; Project Management software; Microsoft Excel software and Microsoft Word software.
Preferred Qualifications:
Experience working in a GMP, FDA, ISO, and USDA-regulated environment.
Familiarity with cGMP and ISO 13485 regulations and practices.
Familiarity with statistical analysis software (Minitab).
Competencies:
Ability to work with mathematical concepts such as ANSI/AQL, probability, and statistics.
Benefits:
Medical, Vision, and Dental Insurance Plans
401k Retirement Fund
About The Company:
Our client is a globally diversified healthcare company with a central purpose of helping people live their healthiest possible lives.
They offer a broad portfolio of market-leading products that align with favorable long-term healthcare trends in both developed and developing markets.
Working with this company, you'll tackle a wide array of problems including some of the world's greatest healthcare challenges while experiencing myriad cultures, geographies, and technologies.
They are creating the future of healthcare through life-changing technologies and products that make you healthier and stronger, quickly identify when you have a medical need, and treat conditions to help you get back to doing what you love.
It serves people in more than 160 countries with leading medical devices, diagnostics, nutrition products, and branded generic medicines.
If you are looking for a great company to work for, look no further because our client has received an average of a four-star rating from its thousands of employees that have written positive reviews on Glassdoor and Indeed.
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