Sr. Manufacturing Automation Engineer

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


This job description will be reviewed periodically and is subject to change by management.
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 | EDUCATION:
• 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 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 audience's 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.


EEO:


"Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of - Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans."