Machine Operator Manufacturing Technician
Resume:
Wali Reynolds
Lawrence, NJ *****
*************@*****.***
Pharmaceutical Lead Technician
Equipment Calibration ~ GCP ~ Manufacturing Methods and Procedures ~Manufacturing
Quality ~
Production Planning ~ Tooling ~ Pharmacology ~ Attention to Detail ~ Thoroughness
~ Documentation Skills ~ Information Analysis
Offer well-developed Industry related skills in : Fette 3200, 2200, BBC4 by layer press with ability to tape feeder frame, Kikusui Libra, 36 station machinery for the generic marketing, Manestry Express 25 station machine with Reject
Mechanism Challenge, Korsch XL 400 Tablet 35 Station Press, Kraemer Testing
System, Smart Test 50, Task Kikusui Measurement Device, and Reconciliation of
Batch
Knowledgeable in encapsulation field, Certified Levels I, II, and III.
Fette technician which includes turret removal from Fette Machine
DEA certified to work with controlled substances
GMP and CGMP knowledgeable
Kikusui Aquarius 36 Station Press, Sejong 36 and 45 Station Press, and MET 30
Plus Metal Detector
Advanced analytical and organizational skills
Exceptional planning, project management and implementation skills
New Operators Trainer skilled in establishing trust and rapport
Initiative-taker, diligent worker who takes initiative
Quick Learning, having the ability to learn new concepts easily.
Highly regarded for an exemplary blend of interpersonal, communication, and listening skills.
Reputation for integrity, commitment to confidentiality, and hands-on leadership approach.
Work Experience
R&D Product Development Technician
Catalent Pharma Solutions - Somerset, NJ
January 2021 to Present
Set up Korsch XL 100, Bonapace XL Incap,
Clatt
CPCG-2 and 5 Fluid Bed Dryer for small scale batches for stability studies
Worked closely with production management/scientist with current and new projects
Interact with clients during and subsequent manufacturing campaigns
Completed batch production record under CGMP and SOPS for FDA approval for clients.
Compression Lead Technician/Setup Technician
Lupin Pharmaceutical - Somerset, NJ
January 2018 to December 2021
Lead operation efforts to ensure facility is functioning at optimal performance level
Set up cadmach C 300 49 station D tooling 61 station B Tooling and Kramer
Deduster and metal detector for manufacturing process
Uploaded tablet recipe for the compression process
Manufactured tablets as per batch record specifications
Submit tablets to QA for manufacturing start up release
Proactively monitored documentation from smart 50 in process tester
Documented in process reading weight hardness and thickness
Proactively monitored the compression process for product quality and investigated/determined and resolved issues when discovered during the manufacturing process
Check batch record for accountability calculations to submit batch record to documentation control department.
Professional Experience continued ...
Manufacturing Lead Technician
Sun Pharmaceuticals - Cranberry, NJ
January 2014 to December 2018
Set up machine for compression manufacturing, ensured Punch Logos were correct and in good condition, Kikusui New Gemini 45 and 55 stations double sided press.
Perform friability and disintegration testing
Resolve issues when discovered
Check batch record readings and calculations to submit batch record to the QA
Department.
Kept equipment operating by following operating instructions; troubleshooting breakdowns; called for repairs when necessary
Updated job knowledge by participating in training opportunities
Manufacturing Technician
OMH Laboratories, Inc. - New Brunswick, NJ
January 2013 to December 2014
Set up machine for compression manufacturing, ensured Punch Logos were correct and in good condition, Kikusui New Gemini 45 and 55 stations double sided press.
Manestry X Press 700 Bi-Layer 49 Stations Press. Nova Manestry 51 Stations press.
Ensure the tablet is in range of the batch record specifications for weight, hardness, and thickness.
Perform friability and disintegration testing
Ensure that the Bi-layer ratio is correct during the manufacturing process
Resolve issues when discovered
Check batch record readings and calculations to submit batch record to the QA
Department.
Machine Operator
West Ward Pharmaceuticals - Eatontown, NJ
January 2012 to December 2013
Set up and disassembled machinery in the manufacturing department
Set punches and dies; made sure to correct filing cam was on the machine
Set filing depth, pre-tablet thickness and main tablet thickness
Ensured the main motor and IDF motor were set correctly
Prepares for production by reviewing production schedule; studying and clarifying specifications; calculating requirements; assembling and weighing materials and supplies
Prepares equipment by performing sterile cleaning-in-place (CIP), servicing-in-place (SIP), and cleaning out-of-place (COP); conducting operator inspections; performing preventive maintenance checks
Produces requirements by operating and monitoring equipment; observing varying conditions; adjusting equipment controls; calculating concentrations, dilutions, and yields; adhering to aseptic filtering and filing procedures
Maintains safe and clean work environment by following current good manufacturing practices (cGMP), and standard operating procedures; complying with legal regulations; monitoring environment
Enhances organization reputation by accepting ownership for accomplishing new and different requests; exploring opportunities to add value to job accomplishments
Completed start-up run to manufacture the product, making sure the reject system was working correctly
Performed visual inspections during the run and made sure the batch record was correct and complete
Submitted completed batch record to Quality Assurance.
Machine Operator
Shire Pharmaceuticals - Owing Mills, MD
January 2011 to December 2012
Set up machine for manufacturing runs, operated compression machinery, Fette
3000, Sejong 36 and 45 stations press.
Performed processing testing during manufacturing, read scales and performed friability testing
Proactively monitored documentation on batch records, troubleshoot and resolved issues when operating the compression machinery.
Operated Glatt GPCG 300, experienced in sieving salts to make drug layering dispersion for coating pellets
Lead in performing spray nozzles to ensure spray level is accurate, took readings during machine operations
Completed product temperature and agglomeration testing, proactively monitored documentation and product quality.
Machine Operator
Sandoz Pharmaceuticals - New York, NY
January 1998 to December 2011
Investigated, determined and resolved issues when discovered while operating high tech compression machinery; lead operation efforts to ensure facility is functioning at optimal performance levels; performed mechanical troubleshooting, set up equipment before productions runs; operating automated assembly process and equipment
Manufactured drugs for generic drug company, completed hardness and thickness testing of tablets; repaired machinery; set up machinery to compress products with ability to start machines for compression runs, proactively monitored documentation and product quality; developed technical expertise and transferred knowledge to associates.
Red scales and performed friability and disintegration testing; operated Bosche encapsulation machine; lead validation testing efforts for batch processing of new and existing drugs being manufactured to ensure FDA regulations was satisfied; assisted with preparation of Factory Acceptance Testing, Site Accepting Testing, and validation activities of the equipment..
Education
University School - Bridgeport, CT
2002
Skills
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