Ryan Mceachern Email & Phone Number

Boston, Ma, Us

Amsterdam, Nl

Validation Engineer (Contract)Moderna, Norwood, MAJune 2021 - Present

Amsterdam, Nl

Validation Engineer (Contract), Sanofi Genzyme, Framingham, MANov 2020 - May 2021Validation Engineer (Contract), Pfizer, Andover, MA Jan 2020 - Nov 2020Validation Engineer (Contract), Rubius Therapeutics, Smithfield, RI May 2019 - Dec 2019• Generated User Requirement Specifications, Risk Assessments and Qualification Protocols/Reports from scratch in support of a new single-use manufacturing facility. • Operated and qualified the following single-use systems: bioreactors, centrifuges, mixing vessels, LOVO cell processors.• Commissioned and qualified critical utilities supplied to manufacturing space including clean compressed air, process gas (Nitrogen, Oxygen, Carbon Dioxide) and HVAC systems.• Commissioned the site building automation system (BAS) used to control air, gas and HVAC systems.• Utilized DeltaV Distributed Control System to operate process equipment and simulate alarms.• Drafted SOPs outlining the operation and maintenance of single-use manufacturing equipment.Validation Engineer (Contract), Takeda, Lexington, MA Jan 2019 - April 2019• Assisted Temperature Controlled Unit (TCU) modification project to relocate monitoring probes to worst-case locations and implement thermal response dampening in an effort to satisfy regulatory requirements.• Developed robust installation and operational qualification protocol to be applied to over 300 TCUs undergoing modification on site. • Participated in cross-functional team meetings to drive project planning, change control strategy, and documentation review/approval.

St Louis, Missouri, Us

Validation Engineer (Contract), Pfizer, North Andover, MAJuly 2018 - Dec 2018• Validation activities required for the modification of an existing suite to introduce a new drug substance • Partnered with automation and process teams to commission new CIP, SIP, process, and transfer phases• Drafted and executed installation qualifications, operational qualifications, and CIP/SIP performance qualifications of process tanks, ultrafiltration skids, chromatography skids and associated transfer piping• Qualified SIP cycles using Kaye datalogger and biological indicators• Assisted CIP cycle development through specification of flow rates and rinse times required for suitable cleaning• Performed cleaning validation by utilizing clean sampling techniques and using LIMS to manage samples and associated dataValidation/Quality Engineer (Contract), Zimmer Biomet, Braintree, MAMarch 2018 - July 2018• Developed Quality Control procedures and test methods to assist product release testing • Specified and ordered necessary equipment and accessories to facilitate laboratory testing • Developed User Requirement Specifications, Installation and Operational Qualification Protocols, and Test Method Validation Protocols for Quality Control test methods• Assisted in lab tech transfer of SOPs and test methods from sister site

Hatboro, Pennsylvania, Us

Validation Engineer II (Contract), Novo Nordisk US Bio Production Inc., West Lebanon, NH • Collaborated with cross-functional team (Engineering, Validation, Manufacturing, Automation, Metrology, etc.) on commissioning and qualification for new process area startup• Executed installation and operational qualification of major production equipment (Bioreactor, homogenizer, microfiltration and ultrafiltration skids, chromatography skids, process tanks, buffer tanks) and clean-in-place (CIP) skids• Managed Hardest to Clean Area cleaning validation study• Performed CIP circuit development testing used for cleaning recipe optimization

Hatboro, Pennsylvania, Us

Project Manager / Technical Writer (Contract), Regeneron Pharmaceuticals Inc., Rensselaer, NY April 2017 – September 2017• Authored SOPs, Work Instructions and Training Evaluations to develop Plant and Clean Utility documentation packages• Gained an in-depth understanding of Water-For-Injection, Clean Steam, Plant Steam, and Domestic Water systems through close collaboration with plant personnel• Supplied on-time project deliverables through development of successful timelines and detail-oriented project management • Presented weekly project reports to client • Managed the on-boarding process and weekly deliverables of an additional project resourceValidation Engineer I (Contract), Novo Nordisk US Bio Production Inc., West Lebanon, NHJune 2016 – April 2017 • Revised user requirement specifications for process equipment and utilities• Drafted design, installation and operation qualification protocols for process equipment and utilities• Executed installation and operational qualification of clean utilities (Purified Water, Water- For-Injection, Clean Steam) and composed the associated reports• Performed moisture testing of plant instrument air• Performed temperature mapping and BI testing of Bioreactor SIP cycle using Kaye Thermal Validator• Performed freezer temperature mapping using Kaye Thermal Validator

Durham, New Hampshire, Us

• Developed and executed test scripts focused on synchronization of clocks in networked devices • Gained valuable industry experience in the formof generating reports and communicating with vendors• Coded using Tcl and gained familiarity with the Linux Operating System• Trained incoming employees on testing protocols and scripting

Bolton, Connecticut, Us

• Analyzed physical and chemical properties of Simoniz products such as pH, refractive index, viscosity, percent of solids, etc., in order to ensure that the quality requirements of each product were fulfilled.• Assisted in formula reworking in order to improve the quality and stability of Simoniz products

Durham, New Hampshire, Us

• Worked to understand and utilize laccase secretion in "Geobacillus Thermoglucosidasius".• Techniques include bacterial cell culture, PCR, gDNA extraction, DNA gel electrophoresis, DNA and plasmid isolation, protein purification, molecular cloning

Us

• Recognized for impressive item scan time. Fastest store-wide scan time in 2011