Responsibilities:

• This role is responsible for providing technical support regarding the execution of 4 Process Performance Qualifications (PPQ) by visiting the tech transfer receiving sites and evaluating the current state of operational readiness through the execution of pFMEA for each site.
• Develop and execute current state operational readiness assessment pFMEAs.
• Report findings with recommendations and escalate critical risks/gaps identified timely.
• Support resolution of identified gaps, identifying root causes and defining. corrective/preventive actions with equipment, processes and automated systems
• Possess demonstrated technical skills and knowledge with biopharmaceutical operations specifically Monoclonal Antibody (Manufacturing).
• Possess understanding of engineering drawings, SOPs, vendor documentation, and other technical documentation.
• Efficiently and effectively manage assigned projects and initiatives.
• As required by group, assist Senior and Principal Engineers on more complex projects/initiatives.

Requirements:

• Bachelor’s degree in engineering or equivalent field.
• 6 to 10 years or role specific experience required.
• Advanced experience executing pFMEAs, PPQs and assessing and reporting on the current state of Operational Readiness.
• Ability to assess and report on process validation activities involving cross-functional teams including Manufacturing, Process Sciences, Process Development, Quality Control.
• Quality Assurance, Regulatory Affairs, and others.
• Comfortable walking through all areas of the production module (CNC space, ISO classified rooms, grey space).Knowledge of the product flow through the various production areas.
• Strong Understanding of process fundamentals and qualification/validation requirements for the following:
• Small molecule chemical synthesis.
• Monoclonal antibody or protein biomanufacturing.
• Cell therapy and regenerative medicine.
• Sterile drug product fill/finish.
• Analytical QC laboratories.
• Computer System.
• Packaging.
• Ability to interact directly and communicate concisely with senior management.
• Advanced Microsoft Project capabilities.
• Familiar with regulatory audit process and capable of assessing provided supporting documents.
• Proficient in computer skills and MS Office applications.
• This role will be traveling to various sites, with some overseas travel required.

• This role is responsible for providing technical support regarding the execution of 4 Process Performance Qualifications (PPQ) by visiting the tech transfer receiving sites and evaluating the current state of operational readiness through the execution of pFMEA for each site.
• Develop and execute current state operational readiness assessment pFMEAs.
• Report findings with recommendations and escalate critical risks/gaps identified timely.
• Support resolution of identified gaps, identifying root causes and defining. corrective/preventive actions with equipment, processes and automated systems
• Possess demonstrated technical skills and knowledge with biopharmaceutical operations specifically Monoclonal Antibody (Manufacturing).
• Possess understanding of engineering drawings, SOPs, vendor documentation, and other technical documentation.
• Efficiently and effectively manage assigned projects and initiatives.
• As required by group, assist Senior and Principal Engineers on more complex projects/initiatives