Engineer Six Sigma

KHILSY K. ALSINA

E-mail: ******.******@*****.***

Telephone: 787-***-****

PROFESSIONAL PROFILE

Talented industrial engineer with over 12 years of experience in the Pharmaceutical Industry.

Proven ability to manage multiple priorities and tasks within a fast paced environment and learn

quickly with minimal supervision. Experienced in all aspects of the Quality and EHS improvement

cycle. Demonstrated ability to influence and be the agent of change at all levels of the organization.

Committed to quality and compliance. Experienced in CAPA, audit management, training, project

management, preventive maintenance, calibration, plant start up, planning & procuring,

development and execution of commissioning and qualification of manufacturing equipment.

KEY ACCOMPLISHMENTS

Key person leading project and initiatives in the Preventive Maintenance, EHS and Quality

Training Systems in the Engineering Department for over 6 years.

Lead a cost reduction project for the Preventive Maintenance System that resulted in a half

million dollars cost reduction by analyzing current process and historic data to increase

effectiveness and eliminate duplicity.

Designed, developed and implemented the systems for the Preventive Maintenance

Program, HEPA Filters Certification Program and Ozone Depleting Chemicals (ODC) Program.

Created the SOP’s, completed all required trainings, and ensured current practices were followed in

compliance with corporate and regulatory agencies requirements.

RELEVANT EXPERIENCE

March 2004 to Present Pfizer Pharmaceuticals Barceloneta, PR

Title: Engineering Compliance Specialist (Via URS Puerto Rico) - Engineering Department

• Monitor CAPA’s department activities and ensure all CAPA’s are closed in a timely manner.

Assist CAPA’s owners with investigation process and provide training as required.

• Lead audit/inspection readiness activities, participate in GMP and EHS regulatory inspections

and audits, and appropriately address outcomes.

• Coordinate compliance remediation projects’ activities with other functional departments.

• Develop, measure and report department key performance indicators (KPIs). Communicate team

progress regarding KPIs’ improvement projects.

• Ensure compliance with EHS and quality requirements for the following programs: Mechanical

Integrity, Pest Control, Preventive Maintenance, Calibration, HEPA Filters and ODC among

others.

• Generate deviation investigations and change request as applicable.

• Develop and implement maintenance cost saving programs; participate and/or lead Process

Improvement strategies.

• Train internal and external personnel in all regulatory programs managed by the Engineering

department.

• Verify activities of contract calibration providers and ensure tasks are performed in compliance

with approved procedures.

• Participate in the execution of Commissioning, IQ, and OQ Protocols for production equipment.

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KHILSY K. ALSINA

E-mail: ******.******@*****.***

Telephone: 787-***-****

Jun, 2003 to Feb, 2004 Merck, Sharp & Dohme Barceloneta, PR

Title: Process Engineer (Via Benjamín Soto & Associates) - Plant 2 API Plant

• Worked in the development of Annual Reviews for existing products.

• Investigation and closure of Process Atypicals, Corporate and Quality Audits and Validation

recommendations.

• Developed and implemented Standard Operating Procedures to support new and existing product

manufacturing processes.

• Collaborated with plant start-up activities such as field support, plant GMP reviews, instrument

classification, interlocks definitions, and new product demonstration.

• Execution of IQ/OQ Protocols for Bulk Manufacturing equipment.

Apr, 2002 to Jun, 2003 Schering- Plough Products LLC Manatí, PR

Title: Project Engineer (Via Benjamín Soto & Associates) - Engineering Department

• Worked in the installation of holding tanks and related equipment for a new manufacturing process at the

site’s API/Steroids Plant.

• Provided troubleshooting, analysis and technical support to the manufacturing facilities as required.

• Provided operator training for all new equipment and support systems.

• Coordinated, monitored, inspected and supervised contractors.

• Assisted in HAZOP analysis.

• Participated in the development and execution of Engineering Commissioning and Qualification

Protocols.

• Created, evaluated and modified SOP’S. Assured all project drawings complied with site and corporate

standards.

• Coordinated validation activities to meet established timelines.

EDUCATION

Bachelor of Science in Industrial Engineering

University of Puerto Rico, Mayagüez Campus

SKILLS

• Knowledge of Current Good Manufacturing and Documentation Practices, FDA, DEA, Training

Techniques and Curriculum, Lean/Kaizen/Six Sigma/ 5S experience.

• Excellent analytical and interpretation skills with regards to written materials, such as technical

materials, regulations, instructions, and reports interpretation.

• Extensive knowledge of all Microsoft Office applications.

• Experienced team-worker and leader.

• Bilingual in English and Spanish.

RELEVANT TRAINING

• Audit Management - Pfizer (2012)

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KHILSY K. ALSINA

E-mail: ******.******@*****.***

Telephone: 787-***-****

• Technical Writing for Investigations (2012)

• Certified Trainer - Train the Trainer Program - Pfizer (2012)

• Six Sigma Training - Six Sigma Consulting (2009)

• IQ/OQ/PQ - Washington Group (2002)

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