Process Engineer - Solution Preparation 

Process Engineer - Solution Preparation 

What you will do 

In this vital role you will be joining the Facilities & Engineering (F&E) group to partner closely with the corporate engineering team to support the design, build, commissioning, and qualification of new equipment and systems needed for drug substance production as well as developing domain expertise to support operations upon start up, focusing on Solution Preparation process equipment. 

Site design, construction, start-up, and operational readiness: 

• Participate in ongoing FATs as well as SATs and continue that support during installation, commissioning and qualification activities of Solution Preparation equipment in alignment with GMP requirements. 

• Ensure systems are installed and operating safety and comply with pertinent environmental health/safety practice, rules and regulations. 

• Support water runs, engineering runs, and process qualification activities for Solution Preparation equipment.  

• Work with existing plant team, including manufacturing, engineering, and maintenance, to support all manufacturing and maintenance procedures, associated job plans, and apply lessons learned to new plant. 

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Site Operations: 

• Provide system ownership and support for Solution Preparation Biopharmaceutical process equipment typically used in biologics manufacturing (e.g. Single-use Mixers, Downflow Boothes, Scales, Stainless Prep/Hold Vessels, CIP Skids etc.) 

• Assist in identifying and implementing engineering-based improvements or upgrades to equipment and unit operation reliability by partnering with cross-functional teams. This may include development of business cases for improvements, identifying design requirements, translating these requirements into process equipment/system design, specifications, and supporting the construction, startup, and validation of equipment. 

• Execute master maintenance program (MMP) to ensure the availability of spare parts and coordinating maintenance activities to ensure systems are in proper working order in partnership with OEMs. 

• Provide technical support to troubleshoot, identify and resolve process and system issues as needed.   

• Provide problem solving support to reduce production downtime. This includes supporting technical root cause analysis and implementation of corrective/preventive actions. 

• Assist with new product/technology introductions by performing engineering and facility fit assessments, implementing equipment modifications, and supporting engineering runs. 

• Communicate with supervisor and support staff to highlight issues and propose solutions. 

• Ensure 24x7 day-to-day reliability for manufacturing operations for Solution Preparation equipment. 

• Participate in rotational on-call support once plant is operational. 

What we expect of you 

We are all different, yet we all use our unique contributions to serve patients. The engineering professional we seek enjoys challenges and is motivated to help serve patients with these qualifications. 

Basic Qualifications:  

• High School Diploma / GED and 10 years of Engineering experience OR

• Associate’s Degree and 8 years of Engineering experience OR

• Bachelor’s Degree and 4 years of Engineering experience OR

• Master’s Degree and 2 years of Engineering experience OR

• Doctorate Degree

Preferred Qualifications:  

• Bachelor’s degree in Chemical or Mechanical Engineering.  

• 6+ years' of relevant work experience with 5+ years' experience in Biopharmaceutical operations/manufacturing environment  

• Direct knowledge of biopharmaceutical production facility with direct experience with Solution Preparation Production (Single-use Mixers, Downflow Boothes, Scales, Stainless Prep/Hold Vessels, etc.), and CIP/SIP Skids. 

• Ability to analyze problems, develop and propose engineering solutions in a scientific manner using data-driven techniques and analyses (e.g., Data Analytics, Root Cause Analysis (RCA), Statistical Process Control (SPC), Six Sigma, Predictive Maintenance, etc.) 

• Experience working in a regulated environment (e.g. cGMP, OSHA, EPA, etc.) and familiarity with GMP quality systems/processes such as change control, non-conformances, corrective and preventative actions, and qualifications/validation 

• Experience applying engineering principles to the design and implementation of system modifications, introduction of new processes, and support of capital projects. 

• Understanding of capital projects in a GMP Biopharmaceutical Production facility including procurement, construction, startup, and validation 

• Understanding of safety requirements working in a GMP Biopharmaceutical Production facility. 

• Independent, ambitious, organized, able to multi-task in project environments, and skilled in communication, facilitation, and teamwork 

• Work schedule flexibility as required to support 24/7 operations, requiring occasional after hours engineering coverage