Katalyst Healthcares and Life Sciences
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.
- s required by group, assist Senior and Principal Engineers on more complex projects/initiatives.
- Bachelor's degree in engineering or equivalent field.
- 6 to 10 years or role specific experience required.
- dvanced experience executing pFMEAs, PPQs and assessing and reporting on the current state of Operational Readiness.
- bility 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.
- nalytical QC laboratories.
- Computer System.
- Packaging.
- bility to interact directly and communicate concisely with senior management.
- dvanced 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.