216 W College Ave.

2nd Floor York, PA 17403

Telephones: 717-845-2922
Cell Phone: 787-914-8341
E-mail: jm4b3ef0@westpost.net

Julio C. Martinez Ocasio

OBJECTIVE: Obtain a challenging position in where I can contribute to the orga
nizational goals with my experience and knowledge and continued to grow professi
onally.
SUMMARY: Extensive experience with Bio-Pharma process equipment, control systems
, computer validation, process & product validation, BAS/HVAC utilities and labo
ratory equipment qualifications. Knowledge in SOP's, ISA Standards, P& ID and MS
DS regulations and Preventive Maintenance procedures. Knowledge in Maximo (Maint
enance and Inventory) Program. Knowledge of Good Automated Manufacturing Practic
es (GAMP), FDA & OSHA regulations and Computer systems knowledge in 21 CFR Part
11. Good working knowledge with Allen Bradley (RS Logix), Omron, Siemens, Wonder
ware batch and HMI software and platforms. Knowledge in QA area for reviewing do
cuments and closing incidents reports (root cause analysis, CAPA and investigati
on closures).
EXPERIENCE:
November 08 - Present AVS (Automation & Validation Solutions), Blue Bell, PA
Position: Lead Validation Engineer
Responsibilities:
* Addimune, Taiwan - Develop commissioning, SAT, and IOQ/PQs for a vaccine manuf
acturing facility, equipment and utilities in compliance with cGMP's. This inclu
des IOQ/PQ development, hands-on execution and report development for the follow
ing systems: CIP/SIP, HVAC with BAS, WFI, Clean Steam, H2O2 Fumigation machine,
facilities and CSV (HVAC with BAS, SCADA for monitoring environmental and proces
s conditions and VMCS (Validated Manufacturing Control System) for product manuf
acture). Also, provide control system, and packaged equipment, startup, commissi
oning and SAT.
Responsible to support the development of IOQ for large incubators, inoculators,
buffer preparation (process tanks), two stages centrifugation, filtration and p
urification systems.
Responsible for preparing and executing computer validation deliverables (user a
nd functional requirements, system specifications, traceable matrix, validation
plan, protocols and SOP's in area such as: PLC (Allen Bradley), HVAC and manufac
turing equipment
Development of turn over packages for the mentioned projects (mechanical and aut
omation parts)
Support client QA in cGxP document review and approval process, mentoring client
personnel, and closing incident reports (root cause analysis, CAPA and investig
ation closures) and resolving technical issues.
January 06 - October 08 Pharmak Group Corporation, Guaynabo, P.R.
Position: Senior Validation Engineer
Responsibilities:
* Hewlett Packard, Aguadilla - Responsible for preparing and executing commissio
ning, equipment, utilities and facility protocols (IQ/OQ/PQ) in process validati
on. Responsible for preparing and executing protocols in compliance with cGMP's
. Responsible for preparing and executing computer validation deliverables (fun
ctional requirements, system specifications, validation plan, protocols and SOP'
s in area such as: PLC (Allen Bradley), HVAC and manufacturing equipment. Respon
sible for preparing SOP's and Preventive Maintenance documents for the systems a
bove. Responsible for supervise validation specialists to complete tasks on a pr
ogrammed schedule.
Support client QA in cGxP document review and approval process, mentoring client
personnel, and closing incident reports and resolving technical issues.
* Bristol Myers Squibb, Manati - Responsible for preparing and executing commiss
ioning, equipment, utilities and facility protocols (IQ/OQ/PQ) in injectable pro
cess validation. Responsible for preparing and executing protocols in complianc
e with cGMP's. Working with laminar flow module, Budzar cooling/heating system,
Nitrogen, WFI, Compress Air and Portable Tanks. . Responsible for preparing an
d executing computer validation deliverables (functional requirements, system sp
ecifications, validation plan, protocols and SOP's in area such as: PLC (Allen B
radley), HVAC, utilities (Water systems) and manufacturing equipment Responsible
for preparing SOP's and Preventive Maintenance documents using Maximo Program f
or the systems above. Responsible for supervise validation specialists to comple
te tasks on a programmed schedule.
Support client QA in cGxP document review and approval process, mentoring client
personnel, and closing incident reports incident reports (root cause analysis,
CAPA and investigation closures) and resolving technical issues.
July 04 - December 05 Alfa Laval Biokinetics, Guaynabo, P.R.
Position: Senior Validation Specialist
Responsibilities:
* Schering Plough, Manati - Commissioning Services at Building 132 and 642. Resp
onsible for development and execution of Utilities Installation and Operational
Commissioning for QC Lab Expansion and API, DI Utility Building. In charge of d
evelopment of turn over packages for the mentioned projects.
* Watson Laboratories, Humacao - Validation Services at Building B-2. Responsibl
e for the development of Computer Installation and Operational Protocols (CIOQ)
for USP Water & BMS Systems. Execute of IQ USP Water Mechanical System Protocol
. Development of User and Functional Requirements Specifications for BMS Contro
l System. Development of the IOQ Protocol for the BMS System.
* Pfizer Pharmaceuticals, Vega Baja - Validation Support Services for Efferdent
Recovery Project- Data gathering, Preparation & Execution of CTP for facilities
. Development of IOQ Protocols for BMS, Mixing System and Compressed Air. Suppo
rt Services for Schleuniger Autotesters - Development and Execution IQ/OQ Protoc
ols for Schleuniger Autotesters.
* Pfizer Pharmaceuticals, Vega Baja - Validation Support Services for Azithromyc
in SR Project Commissioning and Qualification - Development of Installation and
Operational Qualification Protocols for the following: Utilities, HVAC System, C
ompressed Air, USP Water System, Nitrogen and Packaging Equipment (Labeler, Capp
er, Tumbler).
* Pfizer Pharmaceuticals, Vega Baja - Validation Support Services for Azithromyc
in SR Project IT Computer System Validation - Development of Installation and Op
erational Qualification Protocols for HVAC Control System, Compressed Air, USP W
ater System, Nitrogen and Packaging Equipment (Labeler, Capper, Tumbler). Devel
opment of HVAC Impact Assessment Traceability Matrix.
July 01 - June 04 Aker Kvaerner E & C, Caguas, P.R.
Position: Senior Validation Specialist
Responsibilities:
* Services projects sites: Bristol Myers Squibb - Humacao (Edif. 6), Pharmacia -
Caguas (Valdecoxib New Building), Wyeth - Carolina (Par 3), Cardinal Health-Hum
acao, Eli Lilly - Carolina (PR01).
* Responsible for preparing and executing process, product, software, equipment,
utilities and facility protocols (IQ/OQ/PQ) in are such as: injectable and oral
solid dosage process validation. Participate in the protocol execution in comp
liance with cGMP's. Working with dry blending, wet granulation, compression, en
capsulation and coating processes. Responsible for preparing and executing comp
uter validation deliverables (functional requirements, system specifications, va
lidation plan, protocols and SOP's in area such as: PLC (Allen Bradley, Omron, S
iemens), SCADA, DCS, HVAC, utilities, manufacturing, packaging and laboratory eq
uipment. Responsible for preparing SOP's and Preventive Maintenance documents u
sing Maximo Program for the Utilities Department. Knowledge of FDA regulations
for computer systems, 21CFR Part 11 and Good Automation Manufacturing Practices
(GAMP).
January 01 - June 01 Zenith Laboratories Caribe, Cidra, P.R.
Position: Manufacturing Supervisor
Responsibilities:
* Responsible to plan, direct and supervise production activities and employees
in accordance with department policies, procedures and standards to achieve esta
blished production schedules and desired quality levels. Direct, supervise and
assure timely and efficient fulfillment of the areas responsibilities. Schedule
s and coordinates personnel, equipment and activities of personnel, determining
specific work assignments. Promotes continuous quality improvement processes an
d meets profitability goals and customer expectations. Maintains manufacturing
schedules according to requirements on a daily or weekly basis.
October 98 - Dec 00 Procter and Gamble Co., Cayey, P.R.
Position: Making Process Engineer
Responsibilities:
* Supervision of all the activities within the making Department from the Pre-We
ight (raw materials) to the Packing Dept. (finished product). In charge of chan
ge over analysis, cost reduction and process improvement. Analysis of productio
n downtime. Realize capital forms and Plant budget for process improvement and
automation system.
* Administration of GMP, safety and aseptic program in accordance with company p
olitics. Conduct training on an addition of raw materials, security and process
on a Making System Operation. Auditing, preparation and revision of all docume
ntation related to the work area, including GMP procedures. Supervision of the
fill, transport and cleaning of the portable tanks (finish product). Realize no
n-conforming for reject product, Inspections at the equipment and machinery for
their functions, transfer and the SIP/CIP cleaning using the DC computer program
and field observations.
January 98 - May 98 Merck Sharp and Dohme, Barceloneta, P.R.
Position: Process Engineer
Responsibilities:
* Redesign of the F-2 Mechanical Setup System for the Lovastatin Process. Make
improvements at the multifunctional piping line system for a medication product.
EDUCATION: 1998 University of Puerto Rico (Mayaguez Campus)
Bachelor degree in Mechanical Engineering
CERTIFICATION: Participation at the Enterpreneuship & Product Process Developme
nt Exposition at the Mayaguez Campus - November 26, 1997
SKILLS:
* GMP's, Safety and Environmental Regulations and Standards
* Management and Negotiation Skills
* Team worker, Leadership and Self-Starter, Good Oral and Written Communication
* Excellent interpersonal and communication skills
* Analytical and problem solving skill
* Strong computer background. Proficient in Windows Works Office, Word, PowerPo
int, Excel, Mathcad, Quality Windows, Microsoft Project, Maximo, OPQRS, Intellit
rack and Internet
* Bilingual: English and Spanish
REFERENCES: Available upon request.