Senior Maintenance Technician Facilities Engineering

Charles G. Tsakrios

** ****** ******, *********, ** 02472 857-***-**** ***********@*****.***

SUMMARY:

A technically diverse GMP operator with experience in Facilities, Clinical, laboratory and commercial operations for a number of treatment applications. Highly motivated to learn new skills with an adaptive and precise mindset, known for being a can-do team player, eager to succeed, and active in volunteering to help on various projects. Possessing a wide array of scientific knowledge and training, as well as familiarity with HPLC usage and operations, column chromatography and mass spectrometry. Experienced with UV-Vis Spectrometry.

QUALIFICATIONS:

● 3+ years of pharmaceutical manufacturing surgical implant experience with skills in chemistry, microbiology, contamination control, manufacturing, and laboratory operations ● Proven track record for commitment to patients

● Enthusiasm for organizational development

● Comprehensive knowledge cGMP requirements and current industry standards for biopharmaceutical products

● Hard working and committed to future development

PROFESSIONAL EXPERIENCE:

Thermofisher Scientific

October 2023- Present

Senior Maintenance Technician May 2024- Present

Responsible for maintaining facilities equipment and infrastructure as well as maintaining site activities and supporting manufacturing. Responsible for building rounds and troubleshooting of all building systems as well as fixing and maintaining fit and finish of all office and controlled spaces.

●Perform building rounds

●Maintain air handling systems

●Troubleshoot and repair exhaust fan systems

●Room monitoring for temperature, humidity and differential pressure

●VHP setup and breakdown for controlled space sterilization

●Fit and finish work

●Decommissioning of equipment

●Maintenance and operation of gas systems including Oxygen, Nitrogen, and Carbon Dioxide

●Maintenance and operation of WFI systems

●Motor and equipment maintenance of facility systems and GMP equipment including SUMS and other equipment

●Pest control

●Maintenance and operation of refrigeration systems

●Remediation

●Maintenance and operation of diesel generator systems

●Maintenance and operation of fire suppression and safety systems

●Receiving cryogenic material for GMP use.

●Monitor maintain and operate bio waste systems

●Maintain and operate building HVAC systems

●Assist in deviation writing and prevention for manufacturing

●Request and fulfill work orders in Blue Mountain system

●Answering emergency calls for machinery breakdown and difficulty

●Equipment troubleshooting and Engineering assistance

●Provide expertise on machinery including research of technical manuals

●Assisting site security

●Annotate and monitor alarms in PAMS and Delta V.

●Log actions in Kneat

Level 2 Manufacturing Associate (Thermofisher Scientific) October 2023 - May 2024

●Upstream and downstream operations for Viral Vector medicine

●Spray in and sterilization of manufacturing materials for viral vector medicine

●Autoclave and manifolding of materials for use in upstream operations

●Transfection

●Cell incubation

●Cell count

●Aseptic technique

●Sterilize and operate actions within Biosafety cabinets

●Environmental monitoring

●Room clearance

●Action logging in Kneat

●Preparation and usage of Single use mixers

●Calibration and usage of PH and Conductivity meters

●Unicorn systems

●AKTA ready systems

●SAP and goods movement

●Labelling, submission, and handling of samples

●Various SUTFF (Pall systems, etc.)

●Load Harvest

●Gold particle test for nanofilter integrity

●Spectroscopic analysis/Chromatography

Alnylam Pharmaceuticals, Inc.

June 2021 - October 2023

Manufacturing Associate

Responsible for preparing equipment and materials for production, as well as maintaining material inventory. Responsible for the operating of equipment such LNP, SUTFF, peristaltic pumps, and other actions for bulk drug manufacturing. Also responsible for the preparation and review of GMP documents and participating in process investigations and deviations while ensuring GMP compliance and inspection-readiness. Propose and review documentation revisions. Create work orders as needed and coordinate work to prevent maintenance and calibration events from impacting schedule. Identify and implement continuous improvement projects utilizing independent project management skills. Ensure all operations and documentation conform to cGMP standards and that all SOPs and batch records are maintained to reflect current manufacturing methods.

● LNP skid operation for mixing and RNA encapsulation

● Dispensing of lipids and drug substance for weigh and measure

● Lipids and RNA mixing

● SUTFF operation

● PH and conductivity testing

● Solution sampling and delivery to Quality Control

● Dilution and bioburden filtration

● RNA Lipids mixing as well as Chemglass cleaning

● Change Action generation and implementation

● GDP, including logbook review, batch record review, deviation writing, and investigation writing ● Documentation for Quality Assurance

● Assistance with QMS Investigation of failed materials

● Experience in pilot lab studies

● Data mining for operations optimization

● Serving on the EHS board for the site

Thermo Fisher Scientific

March 2021– June 2021

Manufacturing Associate

Support the supply chain for DNA polymerase through the handling and movement of support materials.

● Handle precision optimized polymers used in DNA polymerase such as Formamide ● Working alongside batch chemistry using cGMP and ISO standards

● Preparation and storage of buffer solution

● Preparation and storage of Self Assisted Monolayer solution

● Shipping and handling of materials leaving the site

3D Diagnostix and Biomedical Modelling Inc.

March 2020– March 2021

Production Associate

Assemble and test surgical guides, as well as manufacture surgical models before they're used in dental replacement and maxillofacial reconstruction. Thoroughly test and examine all surgical guides and ensure they or any other products don't have any defects and operate as intended. Communicate with biomedical engineers in Egypt about any design flaws or problems during testing. Communicate with offices in Brazil about hardware fitment issues and stock replacement. Communicate and train dentists and oral surgeons in the use of the surgical devices as well as advised procedures from our engineers.

● Sterilize lab surfaces and log incoming materials

● Intake and analyze stereolithography files from Emails and prepare them for printing in PREFORM CAD

● Physically remove surgical models from the 3D printers

● Clean, trim, and sanitize models and surgical guides for sleeving

● Sleeve and assemble models and surgical guides

● Produce surgical guides for implant surgery

● 3D scan stone molds for stereolithography files

● Pour stone molds from incoming bite trays

● Fit and quality control surgical guides on models and stone molds

● Perform virtual extractions, atraumatic extractions, crestal incisions and enameloplasty on models as per pre surgical instructions including CAT scan images and communicate with dentists and oral surgeons about the nuances of individual guides and models concerning their patient’s needs

● Quality control fitment and reliability of all guide sleeves.

● UV radiate and cold sterilize all guides before shipping

● Clean and maintain 3D printers

● Service lab equipment

● Answer emails and correspond with medical professionals and engineers about the physical guides and models internationally.

● Inventory guide sleeves, laboratory equipment, and office materials

● Correspond between departments for the needs of management and enhance interdepartmental communication

RELEVANT EXPERIENCE:

Manufacturer’s Soap and Chemical LP

September 2000– June 2001

Lab Assistant

Mix and synthesize various lipid compounds of chemical soaps and surfactants. Test compounds for viscosity, perform UV-Vis Spectrometry on samples produced commercially and in laboratory settings. Perform quality control testing and qualitative analysis on commercial batches of soaps and surfactants produced on site. Log and document testing results in lab databases and report findings to senior scientists.

● Maintain laboratory glassware and equipment

● Standardize and calibrate lab equipment

● Perform testing and documentation on various lipids formulations

EDUCATION:

2017-2019 Bunker Hill Community College

- Bio medical engineering (associates in progress)

2005-2006 Hellenic College at Holy Cross

-Religious Studies B.A.

2002-2005 Lee University

-B.S. Pastoral Ministry

Contacts

Michael Cleveland ***************@*****.*** Lead Skilled Tradesman, Facilities (Thermofisher Scientific) 774-***-****

Paul DeMedeiros ***********@*******.*** Associate Director, Manufacturing (Alnylam) 617-***-****

John Michael Maraganore Jr ********@*******.*** Technical Writing Specialist (Alnylam) Omare Zaire ****.*****@****.*** Manager/ Supervisor (3D Diagnostix, Inc.) 786-***-****

Page 4 of 4

Contact this candidate