Engineer Manufacturing

Alexander L. Cariaga

***** ********* ******

Tujunga, California 91042

Home Phone: 818-***-****; Mobile Phone: 818-***-****; e-mail:

*********@*******.***

OBJECTIVE To Obtain a Management Position in Validation and Quality

Engineering

SUMMARY Quality / Validation Experience

Managed and executed validation projects in the areas of

equipment, facilities, process, and equipment cleaning (CIP and

COP) validation. Wrote and executed IQ, OQ, PQ [of new and

existing equipment and manufacturing facilities (HVAC Systems,

controlled and classified rooms, etc.), Process Validation

(manufacturing and cleaning processes), Laboratory Methods

Validation, Commodity Qualification, and Equipment

Requalification protocols. Wrote, reviewed, and approved

validation protocols and reports. Evaluated and analyzed data,

completed final reports and made recommendations for corrective

actions. Prepared report summaries for regulatory submissions

and inspections. Worked on other validation and cGMP projects

concerning analysis of equipment, facilities and process

performance data, process consistency, non-conformance

investigation, requalification, and evaluation of product and

raw material specifications. Wrote and revised validation

corporate policies, standard operating procedures and master

plans. Developed and wrote equipment commissioning and

validation master plans for new and existing manufacturing

facilities.

Manufacturing Experience

Supervised the manufacture of clinical lots, scale-up, process

improvement and modification, and large scale manufacturing of

blood plasma products. Specified processing requirements for the

design and acquisition of process equipment. Wrote manufacturing

standard procedures for the operation of process equipment and

instruments and in-process analytical test procedures.

Conducted personnel training on cGMP and technical/operational

requirements for regulatory compliance.

Laboratory Experience

Performed quantitative and qualitative analytical chemistry

tests using automated laboratory instruments. Performed

stability tests employing protein analysis of marketed products.

Developed assay for quantifying citrate ions and protein

concentration in protein suspensions. Performed methods

validation studies.

Engineering and Process Development Experience

Developed/revised equipment user requirements & system

specifications and commissioned various equipment for biological

and pharmaceutical manufacturing. Prepared equipment

commissioning plans, process validation plans. Developed

cleaning cycles for clean-in-place (CIP) and clean-out-of-place

(COP) systems. Involved in the conceptualization, planning,

construction and commercialization of the first semi-synthetic

antibiotics (penicillins) plant in the Philippines.

PROFESSIONAL EXPERIENCE

Sanofi Pasteur, Swiftwater, Pennsylvania

Validation Technologies, Inc. (VTI)

(Senior Consultant, Engineering and Validation; June 2008 to

Present)

Baxter Healthcare, Thousand Oaks, California

Validation Technologies, Inc. (VTI)

(Senior Consultant, Engineering and Validation; September 2008

to May 2008 )

Anchen Pharmaceuticals, Inc. Irvine, California

Senior Validation Consultant; July 2006 to August 2006

Baxter Healthcare, Los Angeles Fractionation Complex (LAFC), Los

Angeles, California

Principal Engineer; May 2003 to July 2006

PROFESSIONAL EXPERIENCE (Continuation)

Alpha Therapeutic Corporation (Currently Known as Grifols, USA),

Los Angeles, California

Validation Engineer / Quality Engineer; April 1997 to May

2003

Manufacturing Supervisor/Validation Specialist, January 1990 to

April 1997

Methods Validation Chemist, January 1989 to December 1989

Angus Biotech, Long Beach, California

Pilot Plant Supervisor; April 1988 to January 1989

Biotechnics Laboratories, Inc., Los Angeles, California

Analytical Chemist, February 1987 to April 1988

United Laboratories, Inc., Mandaluyong City, Philippines

Project Analyst / Chemical Engineer, July 1977 to June 1985

EDUCATION Completed Course Work Leading to the Degree of Master of

Science in Chemical Engineering

University of the Philippines, Diliman, Quezon City, Philippines

Bachelor of Science in Chemical Engineering, (Full Scholar)

University of the City of Manila, Manila, Philippines

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