Automation & Controls Engineer - Westbrook, ME

Responsibilities

• Carrries 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 company’s policies and practices.
• Supports department by performing related tasks as requested.
• 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.
• Ledges 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 a 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.
• Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Qualifications

• Bachelor's 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.
• 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.).