Engineering Compliance Engineer - Berkshire Sterile Manufacturing : Job Details

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

Regulatory Responsibilities

• Support Quality Assurance Investigation function during FDA, corporate GMPs and customers compliance audits
• Participate in internal audits as applicable

SupervisoryResponsibilities

• Provide leadership in daily operations and have employees incorporate these compliance practices into their daily routines

Experience

• Minimum of five (5) years of relevant post-degree work experience in a technical field in a GMP space

Education

• Engineering degree in a technical field
• An equivalent combination of education and experience may be considered

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

PhysicalRequirements

• Frequent standing and walking throughout the facility
• Satisfactory audio-visual acuity