Senior Manufacturing Engineer Resume

SUMMARY:

Senior Manufacturing/Quality Engineer in the Pharmaceutical and Medical Device Manufacturing Industries seeking challenging, next - level opportunity. Extensive knowledge of cGMP manufacturing, extensive knowledge of computers and software, extensive knowledge of six sigma and lean manufacturing practices, extensive knowledge in documentation practices and technical writing, excellent writing and verbal skills, excellent analytical skills, excellent estimation skills, excellent research skills. Currently becoming proficient in Solid Works.

EXPERIENCE:

Senior Manufacturing Engineer

Confidential

Responsibilities:

Manufacturers of Sterile NiTiNol bone implants.
Duties include Qualification of Manufacturing Equipment, Manufacturing Process Validation, Medical Device Performance Qualification, CAPA Investigations, FAT/SAT, Manufacturing Procedure Development, Equipment Procurement with Capital Expenditure, Risk Analysis, and Manufacturing Cell Development.

Senior Manufacturing Engineer

Confidential

Responsibilities:

Manufacturers of Sterile and Non-sterile Colonoscopy Equipment.
Duties include Qualification of Manufacturing Equipment, Manufacturing Process Validation, Medical Device Performance Qualification, CAPA Investigations, FAT/SAT, Manufacturing Procedure Development, Equipment Procurement with Capital Expenditure, Risk Analysis, and Manufacturing Cell Development.

Senior Manufacturing Engineer

Confidential, San Antonio, TX

Responsibilities:

Charged with qualification testing of medical device production metal fabrication equipment.

Process Engineer

Confidential, Lebanon, PA

Responsibilities:

Process engineer for glass syringe manufacturing facility (startup phase).
Procured supporting packaging equipment.
Qualified and validated processing equipment within an ISO 7 clean room environment.
Tested support utilities (WFI, or Water For Injection, and Clean Compressed Air) for performance.
Implemented maintenance and manufacturing process procedures.
Performed Process and Risk analysis.

Process Engineer

Confidential, San Antonio, TX

Responsibilities:

Installed and commissioned processing and packaging equipment.
Maintained master technical database of all DPT manufacturing and facilities equipment.
Responsible for significant improvements in Change Control.
Responsible for significant improvements in User and Functional Specification Requirements (URS, FRS) for newly acquired equipment.
Generated Capital Appropriations Requests (CARs).
Generated SOPs for operation and maintenance of equipment. Performed Factory Acceptance and Site Acceptance testing (FAT, SAT) of new equipment.
Implementation of lean manufacturing practices, six sigma, statistical process control, and improvements to technical training of operators and technicians.
Responsible for latest approach to Quality by Design (QbD).
IT Liaison to represent the Engineering Department towards training of new file retention and maintenance practices as well as new software implementation.

Qualification Engineer

Confidential, San Antonio, TX

Responsibilities:

Responsible for qualification of several pieces of packaging and compounding equipment towards FDA compliance.
Continued, more focused responsibility for the execution of several engineering line trials and studies resulting in Corrective And Preventive Action (CAPA) resolution.

Validation Scientist

Confidential, San Antonio, TX

Responsibilities:

Responsible for the execution of several cleaning, packaging, and process validation studies towards FDA compliance.
Responsible for qualification of several pieces of packaging and compounding equipment for FDA compliance.
Responsible for the execution of several engineering line trials and studies, with results improving both the volume and quality of manufactured products.

Technical Writer

Confidential, San Antonio, TX

Responsibilities:

Responsible for generating product quotations and technical user manuals of industrial equipment.

Environmental Engineer

Confidential, San Antonio, TX

Responsibilities:

Responsibilities encompassed environmental field work including groundwater monitoring, soil exploration and testing, and environmental equipment maintenance.

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