Sr. Manufacturing Automation Engineer

Please Contact To discuss this amazing opportunity, reach out to our Talent Acquisition Specialist Diresh Krishnan at email address   can be reached on # .

We have Contract role Sr. Manufacturing Automation Engineer for our client at Westbrook, ME. Please let me know if you or any of your friends would be interested in this position.

Position Details:

Sr. Manufacturing Automation Engineer- Westbrook, ME

Location : Westbrook, ME

Project Duration : 12 Months

Pay: $50/hr

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.

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

To discuss this amazing opportunity, reach out to our Talent Acquisition Specialist Diresh Krishnan at email address   can be reached on # .