Christopher Mentas Email & Phone Number

Medford, Ma, Us

Medford, Ma, Us

Novato, California, Us

Novato, California, Us

Novato, California, Us

Novato, California, Us

Tokyo, Jp, Jp

• Provided on-call operational support for engineering systems including UNICORN and SIEMENS. Collaborated with Facilities and Instrumentation groups to make repairs and identify replacement spare parts when necessary. Supported multiple Level II deviation investigations and acted as an engineering Subject Matter Experts(SME) for Root Cause Analysis (RCA) and Corrective and Preventative Action (CAPA) planning discussions.• Served as SME and Administrator for GE UNICORN System, used to perform chromatography process operations. Managed operator and supervisor user accounts. Provided on-the-floor operational support when necessary. Authored and executed multiple Engineering Test Protocols requiring manual manipulation of UNICORN Methods.• Served as SME for multiple deviation investigations surrounding Stainless Steel column frits on 40cm Chromaflow columns. Collaborated with vendors to determine short and long-term solutions, and authored and executed multiple Engineering Test Protocols to determine their effectiveness. Served as technical lead for column conversion project replacing Stainless Steel with Polyethylene column frits.• Supported start-up activities and commissioning of large scale caustic distribution system being installed in manufacturing areas to support commercial and clinical processes, including the mechanical and automation aspects of the of the caustic system and point of use drops. Supported the development of Functional Specifications, User Requirements, and general use Standard Operating Procedures (SOP).• Supported process performance qualifications (PPQ) activities on a post-viral Ultrafiltration/Diafiltration (UF/DF) system. Authored and executed engineering protocols to troubleshoot process issues and train manufacturing technicians.

Tokyo, Jp, Jp

• Perform daily monitoring on current process performance. Use tools such as SIMCA to provide an assessment and work with Manufacturing to give input on forward processing decisions.• Served as subject matter expert (SME) on multiple Level II deviation investigations focused on Chromatography and Viral Filtration process steps. Events included the malfunction of the Unicorn System while running a chromatography method and High Level pressure alarms during the viral filtration process. Participated in root cause analysis and provided full impact assessments when required. • Provided on and off hour coverage to address events, for upstream and downstream processing. Responsibilities include providing guidance to minimize product impact and allow for manufacturing operations to continue. Also provided guidance during daily triage meeting to appropriately Level events and ease the start of any investigation.• Authored protocol for Non-Routine Sampling Plan for clinical manufacturing runs incorporating input from multiple groups. Worked with Manufacturing and Product Development to ensure the successful delivery of developmental samples.• Supported the collaboration and approval on document revisions for multiple Master Batch Records (MBRs). Served as SME on process changes with the revisions to support CAPAs and address potential gaps. Also assisted in the technical review of executed batch records, as part of the Phase III tech transfer into 400 Shire Way facility.• Served as SME to support a Risk Assessment performed on the practice of pooling Unpurified Bulk for downstream purification at both Lexington and Alewife facilities

Paris, France, Fr

The Associate Process Engineer works in the Manufacturing Science and Technology Services group to provide technical support to Commercial Operations at the Framingham Biologics site.Primary responsibilities include:• Supported implementation of Single Use Technology in manufacturing for downstream purification. Participated in the proposal development, project initiation, single use equipment shakedown and testing, and implementation of proposed changes to purification processes, utility and/or facility systems. Including development of procedures and implementation into batch records and Standard Operating Procedure (SOPs)• Generated Non-Routine Sample Requests (NRSRs) and Engineering Test Plans (ETP) to acquire process material for Single Use Technology Stability Studies. Using aseptic techniques filled sample bags with process material and delivered the bags to the stability group for further testing.• Reviewed and executed batch records to gather process data to support ongoing process monitoring and presented data on a weekly basis. Performed daily reviews of chromatograms for specific unit operations and discussed atypical trends that required further investigation with manufacturing and QA. Performed semi-annual Statistical Process Control (SPC) review of the entire purification operation and presented findings to Manufacturing, MSAT, QA, and QC.• Collaborated with cross-functional teams for major deviation investigations and authored risk-based impact assessments to provide justification to forward process material. In addition, assisted in the development and execution of appropriate Corrective and Preventative Actions (CAPAs).• Supported the Critical deviation investigation for a high bioburden on the Ultrafiltration step of the process. Provided on and off hour coverage to remedy the situation, minimize product impact, and allow for manufacturing operations to continue.

Primary responsibilities included working with several process engineers in a project task force environment, developing and revising P&IDs (Piping & Instrumentation Diagrams) utilizing Intergraph SPPID (SmartPlant Piping & Instrumentation Diagram) software. My responsibility entailed working on multiple projects (2-3) concurrently, interacting with separate project groups of process engineers. Projects included Basic Engineering Packages for several different types of petrochemical plants, as well as revamps incorporating preparation of demolition and construction diagrams.

Worked in a project task force environment developing a Process Design Package for BPA plant. Work included developing calculations for hydraulics and pump circuits, developing utility flow diagrams, performing hydraulic calculations for utility systems, and converting Pump and Vessel calculations.Performed special study on a Liquid-Vapor Separation Drum by exploring feasibility of multiple configurations.Performed fire case study on a reaction column to determine the effectiveness of the relief valves.

Primary responsibilities included working with several process engineers in a project task force environment, developing and revising P&IDs (Piping & Instrumentation Diagrams) utilizing Intergraph SPPID (SmartPlant Piping & Instrumentation Diagram) software. My responsibility entailed working on multiple projects (2-3) concurrently, interacting with separate project groups of process engineers. Projects included Basic Engineering Packages for several different types of petrochemical plants, as well as revamps incorporating preparation of demolition and construction diagrams.

Billerica, Ma, Us

Explored the surface of potential raw pigments using Isoelectric Chemistry and presented data to a collaboration of scientists.Constructed new formulations of ink to be tested in displays.Tested performance of ink such as white state, dark state, and dynamic range.Wrote minor script in MATLAB to test new ink as well as optimize new testing device.Work contributed to company reaching year end goal to reach 85 L* on displays.

Master Of Business Administration - Mba

Bachelor Of Science (Bs), Chemical Engineering