ILEANA RIVERA

** ***** ** **********, ** ***** * cel. 787-***-**** *email: acweeq@r.postjobfree.com

PROFESSIONAL SUMMARY

I am a Chemical Engineer with seven years of experience in technical validation, looking to expand my experiences or gain more skills in any engineering related field. Work diligently and effective with project managers, subject matter experts and other departments in order to complete the assigned duties and responsibilities within established schedule and project budget for process/manufacturing equipment.

SKILLS

• Project Management and Organizational skills

• Basic knowledge in CSV

• Knowledge in GMPs, GDPs, GLPs, GEPs

• Self-starter and works with minimum supervision

• Manufacturing and Packaging industry experience

• Other experience includes Biotechnology, Pharmaceutical, Health Care and Medical Devices

• Interpersonal / Facilitation Skills

• Self oriented with project goals

• Effective working in teams or individually

• Familiarized with Six Sigma Tools for process improvements

• Take ownership and leadership on team activities

WORK HISTORY

Validation Engineer, 13/Oct/2015 to 30/Jun/2016

Haemonetics, Inc. – Union, South Carolina

• Plasma Solution Expansion Project Support – assisting in the expansion of the site to increase production capacity for the sale of solutions and grow sales for Plasma customers. For this, Utilities and Process Equipment were acquired providing validation support for activities consisting of the development and execution of URS, FAT, SAT, Commissioning, IOQ, etc. along with project management skills.

• Reverse Osmosis, Multiple Effect Still, Clean Steam, Mixing Tanks, Water for Injection (WFI) Tanks, Fillers, Overwrap Machines, Sterilizer among other equipment and systems were acquired and validated for the new and current process.

• Assisting and coordinating in the Management and Vendors meetings.

• Effective communication, both technical and non-technical topics with all levels of the organization, verbally and in writing.

Validation Engineer, 20/Apr/2015 to 18/Sep/2015

Actavis Laboratories, Inc. – Salt Lake City, Utah

• Coordinate the execution of validation protocols for packaging line integrated equipment, including scheduling, communication, coordination of execution between Manufacturing Engineers, Technology and operating groups to meet project goals.

• Effective communication, both technical and non-technical topics with all levels of the organization, verbally and in writing.

• Validation support and Risk Assessment activities for: Capper Machine, Delta Thin Pouching Machine, Filler, Transfer Pump, Check Weigher, Re-torquer, Induction Sealer and Bottle Cleaner.

Validation Engineer, 23/Sep/2014 to 11/Oct/2014

GlaxoSmithKline (GSK) CPM Panama, Llc. – Panama City, Republic of Panama

• Worked simultaneously in three (3) projects: Dust Collector Replacement, new AHUs additions to existing HVAC Systems, Improvements to Manufacturing Rooms; providing validation support to Senior Engineers and Project Managers during shutdown activities for nineteen (19) consecutive days in a fast-paced environment.

• Perform IOPQ, Final Reports and supporting documentation for mentioned projects.

Validation Engineer, Jun/2013 to Sep/2014, then Oct/2014 to Dec/2014

Bausch+Lomb EB Validation Services, Inc – Greenville, SC

• Perform larger validation / remediation activities (IOPQs, Final Reports and other documentation) for

Filling Lines and Utilities, this last one includes: Hot Purified Water Systems, Clean Steam Systems, Heating, Ventilating and Air Conditioning (HVAC) Systems, Compressed Air and Point of Use Heat Exchangers.

• Planning and prioritizing the project work load in order to ensure that validation activities run smoothly and project deadlines are met; this includes coordinating and performing validation activities within or without production schedule, tracking and reporting the progress of activities, managing project strategies to anticipate or remove obstacles to validation activities.

Technical Writer, May/2013 to Jun/2013

EB Validation Services, Inc – Caguas, PR

• Revision and approval of SOPs in order to comply with cGMPs, standards and regulatory requirements.

Validation Engineer / Specialist, Apr/2013 to May/2013

Olay Validation & Engineering Group, Inc – Cayey, PR

• Assisted with cleaning (CIPs) and sanitization (SIPs) validation executions and documentation, as well as, equipment qualification and process validation.

Validation Engineer / Specialist, Apr/2012 to Apr/2013

Novartis Validation & Engineering Group, Inc – Humacao, PR

• Development and execution of new facilities and equipment Validation and Documentation. Experience included development of IOQs/PQs, User Requirement Specifications (URS), Technical Assessments, Equipment Validation Re-evaluation to comply with regulatory requirements, and Functional Requirements Specifications (FRS).

• Provided support in the execution of CSV tests for PLC, HMI and software applications.

Technical Writer, Dec/2010 to Apr/2012

Amgen Manufacturing Limited Kelly Services – Juncos, PR

• Re-evaluation of SOPs for a better understanding and execution regarding manufacturing processes. This included interaction with personnel from manufacturing areas and quality department, working with documents through an electronic system and applying knowledge of chemistry and engineering principles to improve daily operations that complies with cGMPs requirements.

• Worked with the teams to give recommendations for the modification within quality standard procedures in order to improve manufacturing processes and to reduce company expenses due to non-conformances events.

Technical Writer and Facilitator, July/2010 to Dec/2010

Pfizer Manpower – Caguas, PR

• Provide support to analysts (QA and QO Technical Specialists) in batch records compilation and filing.

• Assist the QA Department with strategies in order to reduce time in the batch records release process.

Chemical Engineering Professional Services, Mar/2010 to July/2010

Danosa Caribbean Inc. – Bayamón, PR

• Liaison between engineers and operators to include interacting and interviewing operators in order to develop process improvement recommendations to evaluate and implement future modifications in the development on polymers, asphalt and others products for the production of waterproof membranes.

• Provide support to engineers working in R&D of new formulas for products, QC/QA inspections, technical writing and laboratory support.

Group Training Leader, Machine Operator, Jun/2009 to Feb/2010

Unilever Co. Caribbean Temporary Services (CTS) – Las Piedras, PR

• Daily task group coordination to meet the production goal for Manufacturing Production areas.

• Provide trainings of the machine operation and process logistic to new hire employees.

• Skills identification between group members, to assign positions and delegate tasks in production lines.

• Report feedback on production details to supervisor on duty.

Researcher Student, Aug/2006 to Nov/2007

Research and Development Center CID – Mayaguez, PR

• Conducted research of the product, service or process using basic engineering principles to understand, and define the commercial drivers for technology development.

• Worked in teams to write and deliver technical/scientific documentation and monitoring reports.

EDUCATION

Bachelor of Science: Chemical Engineering, June 2009

University of Puerto Rico - Mayaguez, PR

Certificate in Industrial Biotechnology: 2009

University of Puerto Rico - Mayaguez, PR

CONTINUOUS EDUCATION / SEMINARS

Have participated and/or taken the following courses / seminars:

•

• Project Management Certification

2014 to present

• cGMPs; FMEAs, Lean Six Sigma tools for improving Process Quality, Speed and

2013

Complexity (DMAIC, 5-Whys, Pareto Analysis, Fish Bone Diagrams, etc.)

• Workshops in Lyophilization and Cleanining Validation Processes

2013,2012

• Introduction to Computerized Validation Systems presentation/workshop

2012

• Basic Nanotechnology Process Certification

2010

• Materials, Safety and Equipment Overview for Nanotechnology Certification

2010

• Waste Water Treatments and Water Purification Certification

2009

• Process/Piping and Instrumentation Diagram (P&IDs) workshop

2007

• Better Process Control School as prescribed by the USFDA

2006

LANGUAGES

Spanish as a native language

Fluent in both reading/writing and spoken English

Intermediate understanding/reading and conversational Italian

Contact this candidate