Process Engineer III, Nucleic Acid - Boston Biotech

Process Engineer III, Nucleic Acid - Boston Biotech

03 Jul 2022
Massachusetts, Boston, 02108 Boston USA

Process Engineer III, Nucleic Acid - Boston Biotech

Vacancy expired!

USD100,000-USD105,000Job ResponsibilitiesProvide 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.

Process Design for Scale-up to ManufacturingParticipate in the oversight during the execution of engineering runs during technology transfer from development to manufacturing.

Monitor, track, evaluate, and report data from unit operations to support project/client communication and deliverables.

Perform statistical analysis.

Respond to and trouble-shoot process issues related to assigned work and areas of expertise.

Assess and select equipment to meet process needs.

Perform material assessments as required.

Develop scientific and technical understanding of unit operations and production processes.

Technology Transfer to GMP ProductionParticipate in technology transfer activities and provide oversight of GMP runs to support technology transfer to production.

Perform key project deliverables for technology transfer activities for new client projects.

Define and justify critical and key process parameters.

Participate in the development of 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/or 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.Basic QualificationsBS or MS in Chemical Engineering/Biological Engineering/Biology or related disciplines with excellent understanding of biotechnology processes

Embodies the Resilience phenotypes of grit, quality + rigor, service orientation, EQ+IQ, builder mentality, velocity, and ownership.

Experience with nucleic acids within a development or GMP manufacturing role.

Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude.

Understanding of quality, compliance, regulatory, and good manufacturing practices.

Demonstrated ability to successfully execute responsibilities in a fast-paced environment, collaborating across functions and multiple stakeholders.

Preferred QualificationsM.S./B.S. in Life Sciences, Chemical or Biological Engineering, or related discipline with ≥ 5 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.

Deep technical, operational, and hands-on equipment knowledge of purification operations including chromatography and filtration (tangential flow, normal flow, and nano), principles of biochemical engineering, and process data analysis.

Excellent communication (oral and written) and attention to detail; ability to present and defend technical and scientific approaches and decisions in both written and verbal form to internal and external partners.

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 (ex. Veeva).

Additional RequirementsOn 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

First-of-its-kind biopharmaceutical manufacturing and technology company offering customized and scalable processes, the highest quality and regulatory capabilities, and world-class talent and facilities for complex and novel medicines. This includes cell and gene therapies, viral vectors, vaccines, proteins, and new discoveries. Through manufacturing that's faster, safer, and more flexible, we safeguard the quality of important medicines and protect the vital supply chain.Exciting opportunity functioning across multiple technical teams

Learn about most advanced technologies in science and engineering

Culture based on core values of: innovation, respect, courage, excellence

Fast Paced Environment

Comprhensive Benefits Package

Vacation & Paid Time Off


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