1. Edwin Mulero
P.O Box 446
Juncos, Puerto Rico 000777-0446
(787) 944-6667 emulero1@prtc.net ________________________________________________________________________
SUMMARYOFQUALIFICATIONS
ManufacturingAssociatewith20yearsof experienceinthebiotechnologyindustry.
Knowledgeableinareassuchas: Quality Process, cGMP Program, Standard Operating Procedures (SOP’s),
Operator of Industrial Lift, Gowning and Aseptic Techniques, EMS, Kaizen, SPC, Zen Shi, Environmental
Monitoring. Baush + Strobel certified.Computerliteratein systems: SAP and Werum, LIMS, EBR, DAS,
HMI. Basic knowledge of English.
EMPLOYMENT HISTORY
Amgen Manufacturing Limited - Juncos, PR 2004 - Present
Associate Manufacturing Fill and Finish (2009 – Present)
(Vial Filling)
 Assembly, set up and operation of automatic line equipment TL and Inova system in critical areas
commercial I and II (Clean Rooms and pharmaceutical isolators).
 Set up and operation of the following manufacturing equipment: Washer, Capper, Baush + Strobel
and Trayloader.
 Vial Inspector
 Works observing aseptic techniques.
 Reconciliation components, bulk and finished product.
 Clean work area and equipment following SOP/ cGMP guidelines.
 Request and return of components and bulk products.
 Pre and Post line of rooms following procedures and cGMP guides.
 Perform SAP and Werum transactions of component, bulk and finished product.
 Monitor environmental using slit to agar plates.
 Take samples required as MP.
 Complete EBR documentation.
 Component, bulk and finished product reconciliations
 Cleaning and sanitation of areas
 Perform activities previous beginning of lots
 Verify EMS report for DP,T, RH and particle conditions.
 Verify filling equipment and accessories.
 Train associates in aseptic area functions.
Associate Manufacturing Fill and Finish (2000 – 2009)
(Syringe Filling)
 Assembled, set up and operated automatic line equipment Cozzoli and SPU in critical areas (Clean
Rooms).
 Managed robotic line.
 Worked observing aseptic techniques.
 Reconciled components, bulk and finished product.
 Cleaned work area and equipment following SOP/ cGMP guidelines.
 Requested and returned of components and bulk products.
 Collaborated in supporting QA, QC and Technical Services.
 Pre and Post line of rooms following procedures and cGMP guides.

2. Edwin Mulero
P.O Box 446
Juncos, Puerto Rico 000777-0446
(787) 944-6667 emulero1@prtc.net ________________________________________________________________________
 Performed SAP and Werum transactions of component, bulk and finished product.
 Monitored environmental using slit to agar plates.
 Took samples required as MP.
 Inspected Syringes.
 Completed EBR documentation.
 Component, bulk and finished product reconciliations
 Cleaning and sanitation of areas
 Performed activities previous beginning of lots
 Verified EMS report for DP,T, RH and particle conditions.
 Verified filling equipment and accessories.
 Trained associates in aseptic area functions.
MFG. Operator III (1994 – 2000)
(Packaging Operator)
 Checked production schedule and determined that adequate materials packing have been
placed at line by material handlers.
 Set-up and operated automatic packing machines (all machines) to meet customer required packing
pattern and protective materials required. Stop line and aside defective materials or packaging.
 Monitored conveyor system to and from packing machine and to manual palletizer. Cleaned minor
jams from the line (any machine).
 Checked layer of for full pattern pack, replacing missing or defective product.
 Recorded production on production schedule. Counted, recorded and disposed of spoilage to
designated location.
 Audited work of others to assure labeling is correct. Picks up WIP material and clinical material and
store in warehouse; move to warehouse, all released raw material from RMQ.
 Identified and checked raw material to be released to other cost centers and move to appropriate
areas.
 Followed SOP’s, MP’s and cGMP’s while doing all above duties.
 Prepared material and packaging components, cleans work area and equipment. Executed
reconciliations, inspects crimps final product container and cleans processing equipment.
Syntex - Humacao, PR 1993 - 1994
Manufacturing Process Operator
Worked in the Formulation area: Fluid Bed Granulator “Glatt” with programmable logic computer system
“PLC”, weighing, screening and milling areas.
EDUCATIONALBACKGROUND
Universidaddel Turabo
Gurabo,Puerto Rico
Bachelor’sDegreeAccountabilitythreeyears