Engineer

States considered: Michigan

Role Description

The Injectable Manufacturing Engineer will work within the Aseptic and Terminally Sterilized Value Streams to support manufacturing and validation/qualification operations.

As well, the Engineer will be responsible for leading technical programs and implementation activities to improve manufacturing processes and maximize the maintenance related uptime and operating efficiencies. These activities help minimize costs and contribute to the profitability and performance of the business.

The ideal candidate will also work in cross-functional teams to identify and implement safety, quality, efficiency and cost improvements (CIP’s) on equipment and processes within operations.   

Responsibilities will include:

• Act as a subject matter expert for sterilization systems.
• Support daily operations activities.  This includes troubleshooting, investigating root cause of deviations, implementing corrective/preventative actions, and implementing process improvements.

• Temporarily assist with annual/periodic requalification of established sterilization systems including but not limited to autoclave, batch and continuous dry-heat depyrogenation, steam-in-place (including vent filters and freeze dryer),gamma/e-beam irradiation, VDmax dose audits, and sterility testing isolators. 
• Lead, execute and deliver annual Continuous Improvement Projects Lead and author deviation investigations to identify root causes and implement corrective actions. 

• Execute qualification/validations/line trials to support projects, including the authoring of change control documents.
• Perform initial qualification of new sterilization systems.
• Assist with the authoring of batch records, protocols and SOPs. 
• Periodic review and/or routine troubleshooting of system failures or deviations, including root-cause analysis and corrective/preventative action implementation.
• Provide support for microbiological and/or validation assessments/evaluations, including using Quality Risk Management tools.
• Provide project management of technical projects to deliver projects on time and to budget.
• Communicates changes and updates to stakeholders.
• Facility support may be required during non-routine hours. 
• Travel to equipment manufacturers and contract sterilizers will be required.
• Promotes the use of Reliability Engineering concepts and tools to the Engineering and Production departments.

• Establishes guidelines and specifications (i.e.: Task, Frequency, Materials, Skill, Calibration parameters, etc.) for properly implementing equipment Preventive Maintenance and equipment health activities.

• Performs reliability analysis (FRACAS, FMEA) to identify root causes of equipment issues.

• Identifies chronic equipment deficiencies through “Bad Actor” analysis.
• Develops procedures and specifications for the reliability maintenance aspects for existing and new equipment.

REQUIRED QUALIFICATIONS

• BS in Biology, Microbiology, Chemistry, or Engineering / related field or 3+ years of related experience and MS Biology, Microbiology, Chemistry, or Engineering / related field
• Basic knowledge of microbiology
• Basic understanding of statistical analysis
• Basic understanding of manufacturing equipment. Experience within a pharmaceutical environment preferred.
• Language Skills: Technical Writing required, along with effective written and oral communication
• Computer Skills:  Microsoft Applications, Minitab or comparable statistical software

DESIRED QUALIFICATIONS

• 5+ years of related experience
• Experience in lean six sigma, value stream mapping, visual management, 5S, etc.
• Experience in injectable manufacturing (aseptic and/or terminal sterilization)
• Prior clean room/aseptic area gowning certification or understanding of qualifications
• Experience with sterilization system qualification

Full time

Regular

Colleague

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