Sr. Manufacturing Automation Engineer

Sr. Manufacturing Automation Engineer

The position of Senior Manufacturing Automation Engineer is within our Infectious Disease Developed Markets Business Unit located in Westbrook, ME. 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.

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 company's 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:

• 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.

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 MS Suites software. (MS Excel, PowerPoint, Power BI)

To discuss this amazing opportunity, reach out to our Talent Acquisition Specialist Diresh Krishnan at View email address on click.appcast.io or can be reached on View phone number on click.appcast.io.

About generis tek: generis tek is a boutique IT/professional staffing based in Chicago land. We offer both contingent labor & permanent placement services to several fortune 500 clients nationwide. Our philosophy is based on delivering long-term value and build lasting relationships with our clients, consultants and employees. Our fundamental success lies in understanding our clients' specific needs and working very closely with our consultants to create a right fit for both sides. We aspire to be our client has most trusted business partner.