Framingham, MA, United States
The Process Engineer III works in the Engineering, Validation & Metrology department and provides expert technical support to Commercial Operations at the Charlton, Framingham and Marlborough facilities. The Process Engineer will provide expertise in troubleshooting problems for manufacturing facilities and metrology functions. The Process Engineer will be responsible for the lifecycle management of various commissioning, qualification, and/or validation facets LFB-USA. In conjunction with other relevant departments, responsible for providing support for troubleshooting problems in manufacturing, specifies, orders and procures equipment used in manufacturing, performs the preparation of engineering and validation documentation for processes and equipment, initiates the production of batch documentation used for engineering and cGMP production.
Provide technical support to GMP operations in a multi-product upstream clarification plant. Area of focus for this position will be clarification, chromatography, buffer preparation, cleaning, utilities (HVAC and water systems), environmental monitoring systems, BMS, shipping validation etc.
Provide engineering study and start up support for tech transfer projects, including preparation of document templates, participation and oversight of testing and lead engineering program management activities for such projects
Partner with Manufacturing and Quality organizations in daily operations to maintain the process in a reliable state of control.
Develop process knowledge and ownership.
Provides technical support and analysis for the resolution of deviations, investigations and process issues.
Identify, own and resolve process and equipment related issues proactively.
Lead the proposal, initiation, testing and implementation of proposed changes to clarification and or purification processes.
Complete technical investigations and provides on the floor technical expertise.
Generate documents (technical memos and reports, protocols, etc.,) related to process non-conformances.
Technical representative for LFB-USA with third party engineering contractors.
Capable of designing new engineered solutions in accordance with our engineering lifecycle program.
Ensure all engineering related documents are up to date and appropriately controlled.
Perform system programming for manufacturing equipment and provide technical support for automated systems.
Participate in the review of processes to achieve cost effectiveness and improved product quality.
Provide troubleshooting expertise for manufacturing of products both internally and externally to the company.Support manufacturing in the investigation of deviations and performs required risk assessments.Provide technical leadership in process/equipment related investigations.The primary objective is to ensure manufacturing processes are capable, compliant, in control and continuously improved.
Communicate process and program robustness to ensure that the engineering lifecycle program remains in a state of compliance and is appropriately funded.
Define relevant operational/technical standards and practices.
Provide on the floor technical support (as required).
Prepare Change Controls, CAPAs and Investigation Reports related to the manufacturing process and utilities.
BS degree in Chemical or Process Engineering or Biological or Pharmaceutical Science. MS degree preferred.
5 years’ experience in the field of biopharmaceutical manufacturing.
Good communication skills and experience in a multidisciplinary FDA/GMP environment are required.
Hands-on experience in running, developing and troubleshooting protein purification, clarification, UF/DF, TFF, and filtration processes and utilities (HVAC and water).
Knowledge of large scale biotechnology unit operations, principles of CIP, principles of biochemical engineering,
Understanding of compliance and cGMP considerations.
Demonstrated commitment to continuous improvement – at the individual, department and organizational levels.
Demonstrated strong technical writing and presentation skills.
Experience in the scale up and operation of large scale biotechnology processes.
Hands-on experience with large scale biotechnology unit operations.
Experience in working with cross functional teams in high paced environment.