Sr. Manufacturing Automation Engineer

Job Title: Sr. Manufacturing Automation Engineer

Duration: 12 Months

Locations: 5 Bradley Drive Westbrook ME 04092

Schedule: Mon-Fri 8:00 AM-5:00 PM

Summary:

This role will be responsible for supporting manufacturing processes quality/cost savings initiatives and implementation of engineering principles while assuring compliance with cGMP quality and safety standards.

Core Job Responsibilities

• Carries out duties in compliance with established business policies and procedures.
• Demonstrates commitment to the development implementation and effectiveness of applicable Quality Processes as per ISO FDA and other regulatory agencies.
• Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the
• companys policies and practices.
• Responsibility to understand and maintain awareness of the quality consequences which may occur from the improper performance of their specific job.
• Support department by performing related tasks as requested.
• Responsible for equipment specification acquisition and implementation.
• Leads automation equipment upgrade efforts related to safety obsolescence and continuous improvement initiatives.
• Evaluates machine logic electromechanical and process controls to troubleshoot equipment and drives to resolution.
• Leads teams to identify root cause of manufacturing failures using structured problem solving. Applies root cause fixes to prevent recurrence.
• Conducts failure modes and effects analysis and evaluates manufacturing equipment risk.
• Completes complex projects based on comprehensive knowledge of manufacturing equipment and processes.
• 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.
• 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.
• Participates in teams as necessary and mentors junior engineers and maintenance technicians to ensure continual improvement safety and compliance.
• Considers safety ergonomic maintenance and operator impact on manufacturing design.
• Interacts with the local Project Management Office on milestones and project status updates.
• Participates in site strategy meetings and planning.
• Leads change through Agile PDM.
• Complies with U.S. Food and Drug Administration (FDA) regulations other regulatory requirements Company policies operating procedures processes and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees customers contractors and vendors.

Basic qualifications education:

• Bachelors degree (BS) in engineering or equivalent combination of education and experience.
• 7 years engineering experience in a manufacturing environment
• Experience in the application of lean six sigma principles and the DMAIC approach or a similar structured problem-solving system.
• Proficiency in change management principles and processes.

Preferred qualifications:

• Prior experience working in a company operating under ISO FDA or similar quality systems or regulations.
• Experience working in a GMP FDA ISO and USDA regulated environment.
• Experience in cGMP and ISO 13485 regulations and practices.
• Experience in statistical analysis software.
• Experience in Microsoft Suites software. (Microsoft Excel PowerPoint Power BI etc.)

Competencies:

General Competencies:

• Innovative Thinking: Independently generates new creative and sometimes unconventional ideas to problem solve or improve current processes and structures
• while seeking feedback from managers and coworkers.
• Multitasking: Demonstrates the ability to handle multiple tasks or responsibilities simultaneously by efficiently managing time prioritizing tasks
• and maintaining productivity across different activities
• Self-Motivated: Demonstrates a proactive attitude consistently drives personal and team goals and maintains high productivity with minimal external supervision.
• Verbal and Written Communication: Effectively conveys ideas in both individual and group settings adapting style and methods to suit the audiences needs both
• verbally and in writing.
• Teamwork and Collaboration: Demonstrates professional cooperation by working together harmoniously with others being an integral part of a team respecting
• others contributions and aligning personal goals with those of the team.

Technical Competencies:

• Fabrication Principles: Proficiency in fabrication principles including CNC lathe milling welding and bolted connections.
• Mathematical Aptitude: Proficiency in mathematical concepts such as ANSI/AQL probability and statistics.
• Technical Aptitude: Proficiency in the ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several
• abstract and concrete variables.
• CAD: Experience in computer-aided design (CAD) and manufacturing software for designing system layouts.
• Materials Testing: Proficient in a variety of testing and measuring methods relating to the process of evaluating the properties and performance of materials used in manufacturing.