Michael Page International Inc. Senior Process Engineer, Downstream - Biotech - Boston in Boston, Massachusetts
Provide technical support to GMP operations in a multi-product and multi-modality facility including both biologics and nucleic acids.
Function as a technical resource for the resolution of deviations, investigations, and process issues. Complete technical investigations and provides on the floor technical expertise.
Generate technical documents (memos, protocols, reports, plans, etc.,) related to process validation, technology transfer, process monitoring, process improvements, etc.
Actively participate in client meetings and serve as a technical SME.
Complete process monitoring tasks that require a variety of statistical and data analysis methods and techniques (e.g., excel, JMP, etc.).
Routinely troubleshoot operational issues for process related operations.
Be a technical resource in the evaluation and implementation of process improvements, policy changes, compliance improvements and optimization programs.
Lead technology transfer activities and provide oversight of GMP runs to support technology transfer to production.
Provide technical leadership and ownership of key project deliverables for technology transfer activities for new client projects.
Define and justify critical and key process parameters.
Develop specifications, standard operating procedures, work instructions and forms to support implementation of new processes.
Collaborate with manufacturing as well as all support functions such as engineering, quality, and supply chain to provide robust and coordinated support.
Perform and support risk assessment activities including hazard and operability studies.
Train production staff to ensure they can perform duties involving new equipment and new processes.
Generate protocols and reports for engineering, clinical, and validation GMP runs.
Prepare change controls and perform change control assessments according to internal procedures as required.
Comply with safety requirements and work to resolve any environmental, health and safety issues.
Optimize processes to effectively and efficiently produce product that meets clients' quality specifications.
MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.
M.S./B.S. in Life Sciences, Chemical or Biological Engineering, or related discipline with ≥ 12 years of relevant industry experience in process development, technology transfer, or GMP Manufacturing.
Experience in the scale up and operation of large-scale biotechnology processes.
Experience developing acceptance criteria for technology transfer and/or validation.
Hands‐on experience with large scale biotechnology unit operations for biologics and/or nucleic acid.
Experience with single use technology and systems.
Experience working for or with contract manufacturing organizations.
Experience owning, managing, and executing change controls and using management systems
On site work required for position
Support 24/7 production/manufacturing activities, which may require off-shift work on occasion including weekends.
Ability to gown and gain entry to manufacturing areas
Our client is a innovative and first-of-its-kind biopharmaceutical manufacturing company focusing on cell and gene therapies. They use cutting edge technology to increase efficiency and accuracy in the manufacturing process, all while maintaining capability to produce both modern and future therapies. These products are made quickly, safely and at scale due to the continuous investment in R&D for next generation manufacturing and development. This company is growing at an exponential rate and establishing state-of-the-art facilities all around the country.
Extremely competitive compensation package
Annual bonus structure
New hire equity package
Full health benefits
Relocation package if necessary
Free parking on site
Michael Page International Inc.
- Michael Page International Inc. Jobs