University of Massachusetts Medical School Process Engineer III in Mattapan, Massachusetts
GENERAL SUMMARY OF POSITION:
The Process Engineer III is responsible for employing good engineering practices (GEP), to apply principles, theories, concepts, industry practices/ standards, and to provide engineering support of biological manufacturing and/or process development operations and capital projects. Additionally, the Process Engineer III applies quality by design (QbD) concepts to evaluate, specify, recommend, and order equipment that is both technically feasible and cost effective; in particular cGMP/sterility driven equipment designs and processes. Develops engineering test studies to acquire data on a variety of process equipment, utilities, components, products, and systems to optimize process performance and/or reliability. Collaborates with Process Development during technology transfer for process scale-up. Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Demonstrates good judgment in selecting methods and techniques for obtaining solutions. Networks with senior internal and external personnel.
Collaborates with vendors or subject matter experts in the development of User Requirements Specifications (URS) and equipment functional specifications (FS) in support of equipment selection and qualifications.
Participates in Vendor Audits, Factory Acceptance Testing, and Site Acceptance Testing generating detailed reports, test scripts and protocols in support of process equipment, facilities, components, products, and systems.
Generates final revision of controlled documentation (SOPs, change controls, P&IDs, deviations, work orders, specifications, amendments, etc.) for approval in support of equipment installation, process changes, product changeover, maintenance, etc. throughout the scope of a project.
Responsible for interpreting data and making detailed recommendations during investigations that have a potential engineering impact.
Supports manufacturing with troubleshooting, root cause analysis, and identifying corrective actions to restore the qualified state of a system, equipment, or process. Ensures that process equipment is maintained in a validated state.
Provides engineering support to Validation and Facilities.
Works effectively with the Automation group to clearly define the scope of the process, alarms, setpoints, etc. to optimize the process control strategy. Collaborate with automation to define new equipment, system, or processes for specifications and design basis of new control systems providing detailed reports and other documentation as required.
Identifies and implements cGMP/sterility, operability, safety and maintenance driven equipment designs and processes; participate in risk based analysis to assure quality, reliability and cost effectiveness of product.
Manages small capital projects, for example in process equipment selection/installation in the manufacturing suite or in utilities.
Performs additional job related duties as required.
Requires a Bachelor’s degree in engineering with a minimum of 5 years relevant experience in a pharmaceutical/biotech environment including cGMP manufacturing and/or process development
Demonstrated ability to evaluate a variety of engineering equipment and make recommendations on the best solution for the business. This includes the demonstrated technical competency in the field of process engineering and ability to perform feasibility studies within in a cGMP environment across functional and organizational boundaries
Prior working experience in cGMP manufacturing/process development clean rooms (e.g. cell culture, purification or fill/finish) required
Ability to work independently on diverse projects and make sound recommendations for solutions
Requires the ability to present information in a clear and organized manner externally and internally to the organization, both written and verbal
Ability to manage multiple priorities and demonstrated excellent time management skills
Ability to lead discussions and present data clearly and concisely to stakeholders and peers
This position may require working off hours depending on the needs of the manufacturing and/or process development
Requisition Number: 2017-29851
Exempt/Non-Exempt Status: Exempt
Company Name (Integration): MASSBIOLOGICS
External Company Name: University of Massachusetts Medical School
External Company URL: www.umassmed.edu
UMass Medical School is committed to being an equal opportunity and affirmative action employer and recognizes the power of a diverse community. We encourage applications from protected veterans, individuals with disabilities and those with varied experiences, perspectives and backgrounds to consider UMass Medical School as their employer of choice.
Review of applications will begin immediately and the position will remain open until filled.