Post on 17-Aug-2015
transcript
General Responsibilities Report to Paul for engineering and facilities projects
Peristaltic Filling Pump Missing Stopper Detection / Inspection Camera System Air Balance Study Security Cameras, Card Access Employee Access Card Creation Maintenance Operating Logs Mini Projects
Assist Tyler and David in their tasks Drawing Control Blue Mountain RAM Pest Control Sound Monitoring
Draft SOP’s New Albany Finished Goods Warehouse Lyman WFI Still
Lyman Shutdown / Construction HVAC Ductwork WFI Piping
Peristaltic PumpWho: Jason Ng, Paul Papali, Watson-Marlow Fluid Technology Group
What: Order a tabletop peristaltic filling pump unit and controller
When: 5/21/15 - Ongoing
Where: New Albany Facility
Why: Initial use for dosing accuracy tests / optimization of parameters / familiarity, understanding of implementation in Marchesini production line
Peristaltic Pump Learn about peristaltic and
other pump solutions (e.g. rolling diaphragm) Mechanics Pros and cons What Flexicon can offer
Contact Watson-Marlow Flexicon Sales Reps
Purchase requests Dosing tests, use in
production line Meeting with reps
Stopper DetectionWho: Jason Ng, Tyler Warner, Lyman employees, Banner Engineering
What: Stopper inspection system for fill line
When: 5/22/15 – Ongoing
Where: Lyman Facility
Why: Ensure product sterility and success of capping mechanism by ensuring proper stopper placement on vials
Stopper Detection Learn how to use camera
Match percentage Area with motion Continuous monitoring
Contact Banner technicians
Acquired mounts, trigger, power supply
Small scale tests Used voltage meter
Implementation Capper machine wiring Shut off Indicator light
Passing the torch
Finished Goods WarehouseWho: Jason Ng, Paul Papali, Stuart Falds, Quinn Parks, Kiana Calvin, Joshua Craig, Faith Denney
What: Create an SOP on operation and maintenance of the New Albany Finished Goods Warehouse
When: 6/16/15 – 7/7/15
Where: New Albany Facility
Why: Provide a more detailed guide / reference to those who oversee the Finished Goods Warehouse
Finished Goods Warehouse Gather resources
and knowledge on warehouse
Draft SOP based on past documents, parallel documents from Lyman
Confer with Quinn, Stuart, Kiana, Faith, Paul for edits
WFI Still Who: Jason Ng, Paul Papali, Ben Logsdon
What: Create an SOP on start-up, operation, and shutdown of the Lyman Steris Finn Aqua WFI Still
When: 6/23/15 – 7/22/15
Where: Lyman Facility
Why: Provide a guide / reference to engineers and mechanics who operate the WFI still, make information easily accessible
WFI Still Read 2, 150-page
manuals on Maintenance and Operation
Learn the science and engineering behind the design of a multiple-effect water still
Draft SOP Consult with Paul and
Ben for guidance and revision
Maintenance Operating LogsWho: Jason Ng, Paul Papali, Don Johnson, Maintenance Department
What: Create daily log sheets for various process, utilities, equipment readings
When: 7/2/15 - Ongoing
Where: New Albany Facility
Why: Streamline / reformat daily readings, encourage daily record-taking, help new maintenance employees gain a feel for reading values
Maintenance Operating Logs Source all logs and
control systems used to record measurements
Compile logs into one standardized format
Understanding of many different process, utilities systems e.g. purified water, plant
steam, RO, etc. Learn from Don about
maintenance operations
Air Balance StudyWho: Jason Ng, David Stanislav, Tyler Warner, Paul Papali, Ben Logsdon
What: Assist in air balance study adjusting pressures in clean rooms
When: 7/15/15 – 7/17/15
Where: New Albany Facility
Why: Evaluate need for change to air handling system, develop understanding of current airflow system
Air Balance Study Survey and label components in
plenum Siemens Building Automation System Control air pressure in Suite 2 Clean
Rooms Manual damper adjustment vs.
automatic PID controls Evaluate need for change Problem solving, critical thinking,
reasoning Improper installation of damper handles Coordinating air supply and return to
achieve set points Finding the source of unexpected results
Lyman ShutdownWho: Jason Ng, David Stanislav, Tyler Warner, Dan Holowecky
What: Assist contractors in construction projects, look over HVAC and WFI piping
When: 7/24/15 - Ongoing
Where: Lyman Facility
Why: Creation of new production line area, additions to piping and HVAC and so on
Lyman Shutdown Study drawings See drawings come to life Document, assist, report, etc. Safety / security (tape, logs) Meeting contractors,
mechanics, etc. Tech Space ladder Observing…
WFI pipe tie-in passivation Various welds Digging out floor for footers Erecting beams, lintels Installation of isolation dampers
Card AccessWho: Jason Ng, Pat Seymour
What: Surveying Card Access Readers
When: 5/20/15 - 6/30/15
Where: New Albany Facility
Why: Improve access system for ease of adjustability, define access levels
Card Access Survey all card access
points Create maps,
spreadsheets eMerge system Improve database
Fixing typos and inconsistencies
Add to drawings Define levels of access
Security CamerasWho: Jason Ng, Pat Seymour, Stephanie Dietz
What: Survey security camera system
When: 6/2/15 - 6/5/15
Where: New Albany Facility
Why: Make information on security camera system readily available, ensure proper coverage
Security Cameras Survey all security
cameras On screen In person
Create maps Plot location Plot span Label
Employee Access CardsWho: Jason Ng, Tyler Warner, Paul Papali
What: Upgrade to new style cards
When: 6/10/15 – Ongoing
Where: All PharmaForce Facilities
Why: Security/safety, clarity and consistency among badge styles
Employee Access Cards Track roster of all
employees Retrieve information
from Gina and HR Communicate and plan
logistics Take pictures Edit and print cards Deliver and assemble
cards So far, finished and
distributed 174 new cards (8 more to go!)
Mini Projects SOP Gap Analysis
Match existing SOP’s to list of procedures / systems
Find out what SOP’s need to be written
Industrial Label MakerSet up software + hardware
Isolating EnclosuresWorked with Ben and JudieSafety of substance weighingRead reports
Internship x Coursework International Law and Global Health
FDA regulation, legal documents Electrical and Computer Engineering
RFID technology, iVu wiring Thermodynamics
WFI Still, energy efficiency Calculus
PID Controls Biology, Chemistry
Drug characteristicsMFG Considerations
ReflectionsFavorite Aspects Recommendations Exploratory, diverse Collaborative,
inter-departmental Challenging Open-ended Flexible REAL projects Multiple projects, full
plate
Shadowing, mentoring Lunch-and-learns
Skills / Knowledge Gained Office / workplace skills, communication (internal and
external to PharmaForce) Understanding drawings / P&ID’s, reading manuals,
drafting SOP’s, filling PRF’s, creating MDT’s, DOCUMENTATION is everything!
Understanding of drug development process from R&D proposal to consumer’s veins
Battling with ambiguity