Sr. Manufacturing Automation Engineer

Sr. Manufacturing Automation Engineer#26-12522

Westbrook, ME

All On-site

Job Description

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.