Engineer, Manufacturing

Manufacturing Engineer II

This is an onsite position. The position of Manufacturing Engineer II 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. 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. If you seek a dynamic role where your contributions will pave the way in developing new products, systems, and processes, come work with us! This job description will be reviewed periodically and is subject to change by management.

Responsibilities:

• Responsible for process development, equipment specification, acquisition and implementation.
• Works to identify 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, and 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 process as necessary
• Participates in teams as necessary to ensure continual improvement, safety and compliance
• Provides training and process expertise for product processing in specific areas such as process development, tooling development and validation.
• Manages engineering project teams and coordinates activities.
• 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 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.