Cathy Downs

Cathy Downs Email and Phone Number

Calibration Technician at Hexagon Metrology, Inc. USA @ Hexagon Metrology, Inc. USA
Cathy Downs's Location
Coventry, Rhode Island, United States, United States
About Cathy Downs

PROFILEDedicated, hard-working professional, Manufacturing Associate with 12+ years experience in the biotech field. Specific skills in Cell Culture technology and a solid understanding of 5S, standard operating procedures (SOP). Equipment monitoring and Aseptic Technique. Team Player with excellent work ethic in a highly-regulated cGMP environment and has excellent communication and organizational skills. KEY SKILL- Electronic Batch Records (EBR) - FDA, EMEA, and Regulatory Audits- Responsible for overall plant safety- Proficient with Control Software: DeltaV, DCS, PLCs and HMI- Has excellent working knowledge of MS Excel and Word- Draft and revise standard operating procedures (SOPs)and master batch records routinely - Train other staff by following Process Procedures according to SOPs. - Execute equipment qualification protocols, Validation.- Proficient in Clean In Place (CIP)- Proficient in Steam In Place (SIP)- Proficient in Aseptic Techniques

Cathy Downs's Current Company Details
Hexagon Metrology, Inc. USA

Hexagon Metrology, Inc. Usa

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Calibration Technician at Hexagon Metrology, Inc. USA
Cathy Downs Work Experience Details
  • Hexagon Metrology, Inc. Usa
    Calibration Technician
    Hexagon Metrology, Inc. Usa May 2018 - Present
    North Kingstown, Ri, Us
    Laser calibration
  • Tedor Pharma, Inc.
    Production Operator
    Tedor Pharma, Inc. Sep 2016 - May 2018
    Cumberland, Ri, Us
  • Cadence
    Edm Manufacturing Technician
    Cadence Apr 2014 - May 2018
    * Works with quality measuring tools to verify product conformity (i.e. micrometers, calipers, optical comparator, microscope, video measuring equipment and CMM ) * Monitors process using quality tools to ensure conformance of products, including following work instructions, prints and other documents.
  • Lonza
    Manufacturing Associate
    Lonza Jan 2013 - Sep 2013
    •LONZA BIOLOGICS, Manufacturing Associate, Hopkinton MA January 2013 – Present (7 months) *Certified to work in a Biosafety Cabinet aseptically sampling and thawing of product.* Working in a cGMP facility manufacturing microbial derived products * Perform basic laboratory tasks (pH, Conductivity, sampling etc…)* Trained & signed off on 100% of CIP/ SIP/ all tank operations/area tasks.* Regular use of Standard Operating Procedures, logbooks and Batch records* Pre-qualified for First level lot review
  • Genzyme Corporation
    Manufacturing Associate
    Genzyme Corporation 2009 - 2012
    GENZYME CORP., Manufacturing Associate, Framingham MA 2009 to 2012 * Large scale Upstream manufacturing Cell Culture Lab, tests including the use of sampling with 2-bottle samplers nova septum bags, aseptic techniques and use of laminar flow hood.* Worked with, YSI, BGA, Osmometor and CEDEX in a cGMP environment.* Assisted in start-up GMP biologics facility* Validation and conformance runs, commissioning of equipment* Conducted review of Batch Records and Log books on the manufacturing floor.* Performed operations on Bioreactors, both small and Large.
  • Lonza
    Manufactuing Associate Ii
    Lonza 2008 - 2009
    Basel, Ch
    * Attended the First URI training for 3 weeks in a class room, consisting of GMP, the history of GMP, upstream process, downstream process on a small scale, lab work And also what QA and QC are responsible for. * Responsible for Cell Culture Laboratory, lab tasks including monitoring of pH, conductivity, dissolved oxygen, using YSI, BGA in a cGMP environment , developing Cells in Shaker Flasks to 10L glass bioreactor then into a stainless steel Seed bioreactor by consistently feeding them with Media, and ending with Harvest transfer to Purification.* Monitored equipment, performed maintenance and troubleshooting equipment to reduce downtime.* Initiation of work orders and Deviations as needed * Used 5S principles to arrange and maintain the Cell Culture area for improved efficiency
  • Amgen Inc
    Production And Cell Culture Associate
    Amgen Inc Jun 2000 - Nov 2007
    * Responsible for running the equipment for simulations prior to starting up of the new manufacturing line for cell culture. Member of the Clean in Place team using caustic to clean the vessels* Became proficient in running the equipment and validating start up systems* Wrote and revised SOP’s with URS’s and P&IDs.* Simulated start-up using Water for Injection in lieu of media and cells.* Subject Matter Expert on all applicable procedures and train new employees as needed in the modules of the SOP’s to reduce errors and improve productivity and efficiency.* Performed lab tasks including cell counting with a CEDEX machine, sampling pH, conductivity, and BGA to ensure healthy growth, using YSI, Osmometer and BGA in a cGMP environment* Ran complex Millipore system which filtered out the old media and dead cells and replenished with fresh media using a Microfiltration skid which results in cell growth used to extract protein for the Manufacturing Process.
  • Stanley Bostitch
    Electronic Assembler
    Stanley Bostitch 1988 - 2000
    * Assembled, tested, and troubleshoot pneumatic nail guns and manual staplers.* Participated in the Quality circle committee to make jobs more productive and economical for the employee and the organization.* Member of the safety committee team that oversaw the overall plant safety. Made weekly rounds and reported to the safety committee on potential hazards to reduce the possibility of accidents (Including hazardous material and chemical information).

Cathy Downs Skills

Gmp Sop Biotechnology Validation Aseptic Technique Fda Biopharmaceuticals Aseptic Processing Cell Culture Purification Manufacturing Lims Capa Change Control Pharmaceutical Industry Technology Transfer Quality Assurance Quality Control Cip Microbiology Deviations V&v Glp Hplc Laboratory Protein Chemistry Protein Purification 21 Cfr Part 11 Cgmp Manufacturing Life Sciences Trackwise Cell Fermentation Cgmp Practices Software Documentation Lifesciences Elisa Quality System Gxp Cleaning Validation Filtration Process Simulation Vaccines Monoclonal Antibodies Biologics Cgmp Documentation Pharmaceuticals

Cathy Downs Education Details

  • Bristol High School
    Bristol High School
    General
  • University Of Rhode Island Feinstein Providence Campus
    University Of Rhode Island Feinstein Providence Campus
    Studied Biotech Manufacturing

Frequently Asked Questions about Cathy Downs

What company does Cathy Downs work for?

Cathy Downs works for Hexagon Metrology, Inc. Usa

What is Cathy Downs's role at the current company?

Cathy Downs's current role is Calibration Technician at Hexagon Metrology, Inc. USA.

What is Cathy Downs's email address?

Cathy Downs's email address is cd****@****dor.com

What is Cathy Downs's direct phone number?

Cathy Downs's direct phone number is +140195*****

What schools did Cathy Downs attend?

Cathy Downs attended Bristol High School, University Of Rhode Island Feinstein Providence Campus.

What skills is Cathy Downs known for?

Cathy Downs has skills like Gmp, Sop, Biotechnology, Validation, Aseptic Technique, Fda, Biopharmaceuticals, Aseptic Processing, Cell Culture, Purification, Manufacturing, Lims.

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