Manufacturing Process Expert
2 weeks ago
About Abbott Laboratories
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines.
Work at Abbott
You can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You'll also have access to:
- Career development with an international company where you can grow the career you dream of.
- Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
- An excellent retirement savings plan with a high employer contribution · Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree.
- A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
- A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.
The Opportunity
This position is within our Infectious Disease Developed Markets business unit located at Scarborough, Maine.
In this role, you will be responsible for supporting product development from concept through sustained manufacturing of FDA regulated products. Completion of process development, equipment acquisition and leadership of supporting development partners. Extensive experience with manufacturing processes, quality/cost savings initiatives and implementation of engineering principles while assuring compliance with cGMP, quality and safety standards.
Responsibilities
- Process development, equipment specification, acquisition and implementation.
- Leads teams to identify root cause of manufacturing failures using structured problem solving.
- Applies root cause fixes to prevent reoccurrence.
- Completes complex projects based on comprehensive knowledge of manufacturing equipment and processes.
- Evaluates machine logic, electromechanical and process controls to troubleshoot equipment and drives to resolution.
- Leads design of experiments, validation, completion of testing and analysis of data.
- Presents data to cross functional teams.
- Drives implementation of 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, and procedures and other technical documents to ensure compliant, efficient and safe procedures
- Leads other engineers and technicians in developing solutions and improvements in materials, equipment and process as necessary in addition to ensuring continual improvement, safety, and compliance.
- Manages cross functional project teams and coordinate activities.
- Contributes to the professional development of engineers and technicians
- Provides training and process expertise for product processing in specific areas such as process development, tooling development, documentation, cleaning protocol, process characterization and validation.
- Initiates and leads to resolution of Quality Incidents and CAPA.
- Ability to travel up to 25% of the time.
Requirements
- Bachelor's degree (BS) in engineering or equivalent combination of education and experience.
- Minimum ten years engineering experience in a manufacturing environment
- Knowledge of Database software; CAD software; Development software; Internet software; Inventory software; Manufacturing software; Project Management software; Microsoft Excel software and Microsoft Word software.
- Familiarity with a variety of material testing and measuring methods
Preferred Qualifications
- Experience working in a GMP, FDA, ISO and USDA regulated environment
- Familiarity with statistical analysis software (Minitab)
- Familiarity with cGMP and ISO 13485 regulations and practices
Salary
The estimated salary for this position is between $83,000.00 – $166,000.00. In specific locations, the pay range may vary from the range posted.
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