Machining Engineer
Manufacturing Engineer III-Middletown VA Position SummaryThis 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 initiativesDevelop 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 exceededDrive projects to closure; track timelines and remove roadblocks encountered by the teamMentor and coach junior engineers and techniciansFollow all safety and current Good Manufacturing (cGMP) requirements within the plantDevelop 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) activitiesCreate, implement, and document all validation activities within the plant-based systemUse Design of Experiments (DOE) to optimize critical process parameters of manufacturing systemsParticipate as critical team member on project teams to start-up new facilities, equipment or processesPerform trending and monitoring of critical quality attributes and critical process parameters to maintain product quality and control process driftData driven- champion the use of data visualization and analytical tools throughout the manufacturing environment including Statistical Process ControlDocument studies, changes and improvements throughout the Quality Management System in the form of CAPAs or other investigationsComplete laboratory and measurement-based studies and write technical reports summarizing results with emphasis on technical difficultyDrive process improvement opportunities and/or corrective actions to increase yield, improve production capacity, reduce cost and decrease process variability while maintaining regulatory complianceSupport all aspects of engineering, manufacturing, and research and development as neededSelf-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 environmentProject leadership experienceAbility to lead people as direct supervisor or in a matrix environment; coaching and mentorship skillsExperience with validation engineering in a regulated environmentStandards knowledge including ISO9001 and ISO13485Proficient in MS OfficeAbility to create detailed timelines (ie MS Project or similar), lead project teams, host team meetings and ensure project successExcellent technical capabilityEffective communication skills both written and verbalPositive, can-do attitude and able to work independently and as a member of a multi-functional team; team-playerAbility to work in fast-paced results orientated environmentDesire to contribute to the business and its teamHighly organized and self-motivatedVery hands-on work ethicFlexible availability in hours if neededPreferred 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 initiativesDevelop 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 exceededDrive projects to closure; track timelines and remove roadblocks encountered by the teamMentor and coach junior engineers and techniciansFollow all safety and current Good Manufacturing (cGMP) requirements within the plantDevelop 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) activitiesCreate, implement, and document all validation activities within the plant-based systemUse Design of Experiments (DOE) to optimize critical process parameters of manufacturing systemsParticipate as critical team member on project teams to start-up new facilities, equipment or processesPerform trending and monitoring of critical quality attributes and critical process parameters to maintain product quality and control process driftData driven- champion the use of data visualization and analytical tools throughout the manufacturing environment including Statistical Process ControlDocument studies, changes and improvements throughout the Quality Management System in the form of CAPAs or other investigationsComplete laboratory and measurement-based studies and write technical reports summarizing results with emphasis on technical difficultyDrive process improvement opportunities and/or corrective actions to increase yield, improve production capacity, reduce cost and decrease process variability while maintaining regulatory complianceSupport all aspects of engineering, manufacturing, and research and development as neededSelf-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 environmentProject leadership experienceAbility to lead people as direct supervisor or in a matrix environment; coaching and mentorship skillsExperience with validation engineering in a regulated environmentStandards knowledge including ISO9001 and ISO13485Proficient in MS OfficeAbility to create detailed timelines (ie MS Project or similar), lead project teams, host team meetings and ensure project successExcellent technical capabilityEffective communication skills both written and verbalPositive, can-do attitude and able to work independently and as a member of a multi-functional team; team-playerAbility to work in fast-paced results orientated environmentDesire to contribute to the business and its teamHighly organized and self-motivatedVery hands-on work ethicFlexible availability in hours if neededPreferred 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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