Position Summary | The Engineering Compliance Engineer is a hands-on role responsible for overseeing and managing the investigation and on time closure of equipment deviations, equipment records review process, and compiling performance metrics within the equipment, facilities and validation functions. | |
Duties and Responsibilities | - Manage the timely review and investigation of equipment-related deviations and respond to equipment record queries from internal/external sources
- Oversee timely completion of any required Engineering-related corrections within quality events in accordance with the procedural requirements
- Ensure all deviations from established procedures are appropriately documented and investigated to determine and fix root cause
- Assist with implementation and supporting on-going continuous improvements
- Lead the root cause analysis for Deviations and CAPAs and interface cross functionally to make sure all Deviations/CAPA's are completed on time in accordance with batch release schedule
- Prepare and publish weekly departmental metrics
- Contribute to development and validation of process improvements, SOPs, and
staff training - Facilitate continuous improvement projects related to deviation and CAPA investigations
- Assist in compiling information for the Key Performance Indicators (KPI) on an as needed basis
- Attend and complete all mandatory training
- Demonstrate SSM values and behaviors at all times
- Other duties as assigned
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Regulatory Responsibilities | - Support Quality Assurance Investigation function during FDA, corporate GMPs and customers compliance audits
- Participate in internal audits as applicable
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Supervisory Responsibilities | - Provide leadership in daily operations and have employees incorporate these compliance practices into their daily routines
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Experience | - Minimum of five (5) years of relevant post-degree work experience in a technical field in a GMP space
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Education | - Engineering degree in a technical field
- An equivalent combination of education and experience may be considered
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Knowledge, Skills & Abilities | - Proficient in the use of MS office applications such as Word, Excel, PowerPoint and Adobe Acrobat
- Basic understanding of cGMPs and of regulatory requirements as they apply to the pharmaceutical field or a related area
- Familiarity of engineering concepts
- Time management
- Attention to detail while executing multiple tasks
- Well-organized
- Good oral and written communication skills, i.e. effective presentation of concepts and ideas, as well as interpersonal and conflict resolution skills
- Root Cause Analysis training including tools such as 5-whys, fishbone diagram, and FMEA is desirable
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Physical Requirements | - Frequent standing and walking throughout the facility
- Satisfactory audio-visual acuity
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