Manufacturing Engineer 3
Manufacturing Engineer III-Middletown VA Position Summary This position is under the direction of the Process Engineering Manager and includes responsibilities related to leading projects aimed at designing, implementing, and documenting validation engineering activities as well as to develop and improve processes to drive productivity, capacity, cost reduction and efficiency.
Responsibilities:
Lead projects and people aimed at excellence in safety, quality, process engineering and validation initiatives Develop project plans against business objectives, work multi-functionally to ensure objectives are clear and well-defined, exercise an eye for business across the site to ensure project achievements and met and exceeded Drive projects to closure; track timelines and remove roadblocks encountered by the team Mentor and coach junior engineers and technicians Follow all safety and current Good Manufacturing (cGMP) requirements within the plant Develop and implement Field Acceptance Testing (FAT) and Site Acceptance Testing (SAT) using User Requirement Specifications (URS) Lead validation engineering activities including Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) activities Create, implement, and document all validation activities within the plant-based system Use Design of Experiments (DOE) to optimize critical process parameters of manufacturing systems Participate as critical team member on project teams to start-up new facilities, equipment or processes Perform trending and monitoring of critical quality attributes and critical process parameters to maintain product quality and control process drift Data driven- champion the use of data visualization and analytical tools throughout the manufacturing environment including Statistical Process Control Document studies, changes and improvements throughout the Quality Management System in the form of CAPAs or other investigations Complete laboratory and measurement-based studies and write technical reports summarizing results with emphasis on technical difficulty Drive process improvement opportunities and/or corrective actions to increase yield, improve production capacity, reduce cost and decrease process variability while maintaining regulatory compliance Support all aspects of engineering, manufacturing, and research and development as needed Self-motivated with good problem solving, communication, coordination, and mentoring skills
Qualifications:
Bachelor's degree in Engineering, Statistics, Technical or related field (Master's preferred) 5 years or more proven experience in manufacturing environment Project leadership experience Ability to lead people as direct supervisor or in a matrix environment; coaching and mentorship skills Experience with validation engineering in a regulated environment Standards knowledge including ISO9001 and ISO13485 Proficient in MS Office Ability to create detailed timelines (ie MS Project or similar), lead project teams, host team meetings and ensure project success Excellent technical capability Effective communication skills both written and verbal Positive, can-do attitude and able to work independently and as a member of a multi-functional team; team-player Ability to work in fast-paced results orientated environment Desire to contribute to the business and its team Highly organized and self-motivated Very hands-on work ethic Flexible availability in hours if needed Preferred Requirements:
Statistical engineering skills (ANOVA, DOE, parametric, non-parametric tools, SPC, etc.
) and software platforms (Minitab, JMP) Mechanical engineering skills (Solidworks, AutoCAD) Six-Sigma knowledge/certification.
Estimated Salary: $20 to $28 per hour based on qualifications.
Responsibilities:
Lead projects and people aimed at excellence in safety, quality, process engineering and validation initiatives Develop project plans against business objectives, work multi-functionally to ensure objectives are clear and well-defined, exercise an eye for business across the site to ensure project achievements and met and exceeded Drive projects to closure; track timelines and remove roadblocks encountered by the team Mentor and coach junior engineers and technicians Follow all safety and current Good Manufacturing (cGMP) requirements within the plant Develop and implement Field Acceptance Testing (FAT) and Site Acceptance Testing (SAT) using User Requirement Specifications (URS) Lead validation engineering activities including Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) activities Create, implement, and document all validation activities within the plant-based system Use Design of Experiments (DOE) to optimize critical process parameters of manufacturing systems Participate as critical team member on project teams to start-up new facilities, equipment or processes Perform trending and monitoring of critical quality attributes and critical process parameters to maintain product quality and control process drift Data driven- champion the use of data visualization and analytical tools throughout the manufacturing environment including Statistical Process Control Document studies, changes and improvements throughout the Quality Management System in the form of CAPAs or other investigations Complete laboratory and measurement-based studies and write technical reports summarizing results with emphasis on technical difficulty Drive process improvement opportunities and/or corrective actions to increase yield, improve production capacity, reduce cost and decrease process variability while maintaining regulatory compliance Support all aspects of engineering, manufacturing, and research and development as needed Self-motivated with good problem solving, communication, coordination, and mentoring skills
Qualifications:
Bachelor's degree in Engineering, Statistics, Technical or related field (Master's preferred) 5 years or more proven experience in manufacturing environment Project leadership experience Ability to lead people as direct supervisor or in a matrix environment; coaching and mentorship skills Experience with validation engineering in a regulated environment Standards knowledge including ISO9001 and ISO13485 Proficient in MS Office Ability to create detailed timelines (ie MS Project or similar), lead project teams, host team meetings and ensure project success Excellent technical capability Effective communication skills both written and verbal Positive, can-do attitude and able to work independently and as a member of a multi-functional team; team-player Ability to work in fast-paced results orientated environment Desire to contribute to the business and its team Highly organized and self-motivated Very hands-on work ethic Flexible availability in hours if needed Preferred Requirements:
Statistical engineering skills (ANOVA, DOE, parametric, non-parametric tools, SPC, etc.
) and software platforms (Minitab, JMP) Mechanical engineering skills (Solidworks, AutoCAD) Six-Sigma knowledge/certification.
Estimated Salary: $20 to $28 per hour based on qualifications.
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