Validation Engineer

Brian Evans

*** ****** ***.

San Marcos, CA *2078

Telephone: 760-***-****

Email: **********@*****.***

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SUMMARY OF KEY SKILLS AND QUALIFICATIONS

. An accomplished Validation Engineer, IT Technician and Field

Service Engineer with 15 years of combined experience:

principally pharmaceutical, medical device and health care

industries.

. Process Validation, Qualification of Equipment, Building

Automation System (BAS, BMS), and Process Automated Equipment.

Documentation of Regulatory Compliance and FDA regulations

21CFR, part 11, 58, 210, 211, and 820. Validation

protocols/reports (IQ, OQ, & PQ) Test plans / scripts. Monitored

critical environments and ensured strict adherence to specified

operating conditions, such as those in manufacturing, isolation

rooms, and clean rooms.

. Completed all engineering deliverables necessary to advance to

subsequent stages of product development, including detailed

manufacturing, validation and qualification plans.

. Experienced in commissioning and qualification of WFI

Distribution recirculation system (Hot loop operating at

required >65 C and desired >80 C), which included the connected

AWFI (Ambient WFI operating at 20 C 5 C) distribution system,

distillate reject lines and drain coolers, as well as

associated piping and ancillary components. The WFI in bulk was

sterile-filtered and processed aseptically in a class A

cleanroom environment. It had very low conductivity and a very

low concentration of organic components (TOC, total organic

carbon). In order to ensure that the water was of sufficient

quality, in addition to the in-process monitoring of the

electrical conductivity, the microbiological parameters were

also regularly monitored, and the parameters were amongst those

that were determined: number of colony-forming units (CFU) of

aerobic bacteria. WFI was intended for use in the manufacture of

liquid to semi-liquid parenteral administration.

. Experienced in developing and executing cleaning protocols in

line with current industry standards. Provided a hands-on

approach to help guide clients through the details of

establishing a cleaning master plan including setting residue

acceptance criteria, preparing a comprehensive sampling plan for

validating, and utilizing appropriate qualified analytical

methods with sufficient sensitivity for their unique processes

and equipment within API and APA Manufacturing Plants.

. Effectively communicated with cross functional teams in order to

plan, execute and resolve any issues.

. Project management, leadership and team building experience

. Excellent oral and written communication skills including

analytical, troubleshooting and a strong passion for providing

first in class customer service and meeting deadlines

consistently.

. New system development and launch experience; system lifecycle

management

. Performed QA reviews of training records to ensure compliance

with SOP training manual and regulations.

. Reviewed equipment calibration, validation, and maintenance

records to confirm they meet performance requirements in a

timely manner.

. Performed QA review of deviation & final reports.

. Reviewed and approved validation and engineering documents,

change control, CAPA, and other supporting documentation.

QA experience in all phases of life cycle, including

requirements gathering, risk analysis, project planning,

scheduling, testing, defect tracking, management, and

reporting.

Adept at using both manual and automated testing tools to

troubleshoot systems, integration, user acceptance, positive

and negative, functionality, object, and regression.

Develop use cases, user interface specifications, and user

requirement specification documents.

Liaised with developers, business analysts, and user

representatives in application design and document reviews.

Professional Experience:

Dates Aerotek Engineering, Melville, New York

3/2012 - 12/2012 Validation Engineer

. Development and Execution of Validation Program Deliverables:

Commissioning, Qualification, Validation Summary Reports,

Deviation Reports, Addendums, Amendments, IQ, OQ, PQ, FQ, User

Requirements Specifications, System Design & Functional

Specification.

. Commissioned, and qualified including P&ID Walk-down

verification and qualification for the following Process

Equipment systems: WFI tanks (jacketed vessels) and Purified

water, Control Valves, Heat and Cooler Exchangers, CIP, SIP,

Autoclaves (including cycle development studies), Vial Washers,

Depyrogenation Tunnel, including centrifugal pumps, motors,

Nitrogen and VFD's servicing Aseptic Processing Areas within API

Manufacturing Plant.

. Participated in installation, and field testing of legacy

filling equipment, and start-up of parenteral areas and critical

clean utility systems for Manufacturing. Prepared and performed

the qualification protocols (IQ's, OQ's, and PQ's) for critical

utility systems and parenteral operation complying with VMP, ISO

and FDA standards. Coordinated support activities with other

departments such as maintenance, quality and production. Worked

closely with the quality control department in the routine

monitoring program to ensure critical utility systems maintain

quality and reliability standards in addition to maintaining

validation life cycles.

Dates Validation Technologies Incorporated, San Diego, California

10/2006 - 12/2011 Validation Engineer

. Responsible for validation, commissioning, quality assurance and

cGMP compliance activities for clients at various sites within

FDA regulated industries including medical device,

pharmaceutical, and Health Care facilities.

. Accurately performed various cleanroom validation tests such as

filter integrity testing, particle counts to control airborne

contaminants both in clean rooms, clean zones and cleanroom

hoods (laminar and non-laminar flow hoods) within positive and

negative pressure differential environments.

. Developed and executed CQ/DQ/I/OQ/PQ protocols for Process

Validation, Equipment Validation and Automated Control systems.

. Author and Executed Cleaning Validation IQ/OQ Protocols.

. Performed swabbing for Cleaning Validation Studies

. Responsible for taking samples and swabbing of Clean

Equipment

. Generated Product and Equipment Matrix for Small utensil

Equipment

. Generated and Executed Cleaning Validation Protocol and

Reports

. Experienced in FAT and SAT testing.

. Skilled in Temperature (thermal) Mapping studies, calibrating

and operating a Kaye 2000 Validator and Veriteq Data Loggers

including instrument calibration using NIST traceable standards

for Cold Rooms and -80 C Freezers.

. Managed, programmed and qualified Siemens Apogee (BMS) Building

Management System; HVAC Systems; Steam Generators (boilers),

Cooling Towers, Vaporizers, Humidifiers, Dehumidifiers, Chilled

Water, Process Gas Systems; Compressed (Clean) Dry Air; Purified

Water System, RO/DI, WFI Tanks, CIP, SIP, Nitrogen Systems,

Lab Systems Remediation, Facility Architecture and Finishes.

. Prepared Final Report packages including analysis and

Summary Reports.

Dates Ellipsis, Inc. Aliso Viejo, California

10/2001 - 9/2006 QA Systems Analyst / IT Technician

. Utilized strong customer and technical skills supporting

software and hardware services to end-users in the medical

field.

. Provided software installation / configuration including System

monitoring via remote log in with high-level customer care,

training, and technical support.

. Thorough tracking of issues in CRM software program.

. Assembled and installed a wide array of computer systems,

workstations, and peripheral hardware.

. Provided end user support, maintained printers, devices and

desktops.

. Maintained support of the local network and servers ensuring

backup systems operated effectively.

. Troubleshot hardware and software issues on both the network and

desktops.

. Knowledge of windows network operating systems including active

directory.

. Completed all required administrative functions in an accurate

and timely manner.

. Provided first in class customer service to staff and clients.

. Demonstrated strong interpersonal, critical thinking skills and

actively participated as a team player and problem solver.

. Analyzed business and system requirements, development of

specifications to create and execute detailed test plans, and

verify bug fixes.

. Assured test data, scheduled automated/manual tests. Approved

results documentation and tracking systems updates.

. Supervised development of SQL-queries/procedures for database

and backend testing.

. Managed script creation for regression and stress testing using

Load Runner and QuickTestPro.

. Used Clear Quest for repository, reporting and tracking bugs,

and providing updates on resolved bugs.

. Analyzed application, system, and security errors. Escalated

issues to developers and verified fixes.

. Attended weekly defect report meetings and presented progress updates.

Dates 24 Hour Fitness Rancho Santa Margarita, CA

6/1998 - 8/2001 Sales Representative, Assistant Fitness Manger/Personal

Trainer

. Proven ability to sell and effectively close sale; retaining client

satisfaction.

. Demonstrated skills in exercise/nutritional science, sports

specific methodologies, cardiovascular prevention modalities for

athletes and clients.

. Developed and educated client base to meet the requirements of a

moderate volume-low intensity to a high volume-high intensity

training period to build muscle, lose body fat, increase

strength, maximize performance and minimize over-training.

. Provided fitness and goal assessments including vital

statistics, glucose monitoring, body composition testing and sub-

maximal oxygen consumption testing as a basis for program

design.

. Managed and monitored proper nutrition (meal planning) including

supplements, weight management and clinical care.

Dates Precision, Incorporated Huntington Beach, CA

5/1988 - 4/1998 Field Service Engineer

. Serviced and maintained a full territory of electronic equipment

and configured software installs and updates.

. Resolved at least 85% of service calls within an assigned

territory.

. Accurately performed all electro-mechanical and electronic

adjustments on equipment as outlined in the Technical Service

Manual and Field Engineering Bulletins.

. Ability to read and interpret schematics and complete all

electrical troubleshooting as outlined in the Technical Service

Manual and Field Engineering Bulletins to include our complete

Bio-Medical digital line of products.

. Resolved all normal customer relational situations and

communicated unusual customer situations to a higher level.

. Maintained parts inventory and achieved acceptable levels of

inventory control and usages.

. Completed all required administrative functions in an

accurate and timely manner.

Education:

. 2009 - International Society for Pharmaceutical Engineering- Member

. 2007 - CAL-OSHA Certified in Safety and Regulation

Compliance

. 2000 - ICT, CompTia A+, and MCP certifications of Microsoft

Applications and Office suites

. 1999 - National Academy of Sports Medicine,

Certification

. 1981 - Orange Coast College, courses in Computer

Management and Music

Strengths:

. Work ethic - self starter; dependable; meet deadlines; high

level of integrity and honesty; strives for excellence

. Communication Skills - great listener perceptive of individuals

and their potential; diligent in educating and being understood.

. Organization/Administration - multi-task oriented; skilled at

implementing systems and procedures.

. Analytical/Problem Solving Skills - quick learner; ability to

provide excellent service in area of need of individuals and

programs.

. Leadership - ability to manage and motivate varying

personalities and empower each individual to be successful.

Contact this candidate