Profile:

An independent contractor, with 11 years of experience in the pharmaceutical and medical device industry and 10 more in pulp, paper, and petrochemical industry.

An expert interpreting FDA pharmaceutical CFR Part 210, 211, medical devices Part 820,electronic records and signature Part 11 compliance and technical writing. Provides software quality assurance for product development and authors standard operating procedures and training manuals. Effectively executes, and audits validation protocols for installation, operational, and performance qualification. For medical devices, provides similar activities to ensure compliance with required design verification and validation regulations.

Verification & Validation Areas:
Process, Utility, Thermal, Computer system, Control systems, Auditing, New product development, Test method validation.

Skills:

Learns and adheres to company policies, applies FDA, ISO, and international regulations effectively
Adapts to a company's business decisions to keep projects on track
Writes clearly and concisely, validation documentation, work instructions, and final reports
Transfers experience from 11 years of contracting experience from top-ranked companies
Plans and implements actions required for new product development and remediation efforts
Performs tasks with no direct supervision and within project teams
Easily adapts to changing priorities and work assignments
Identifies and reports compliance and non-conformance issues to achieve effective resolution

Experience:

Validation Engineer, Confidential, (11/09 - Present)

Wrote new validation test protocols. Changed existing validation test protocols. Executed protocols for an ablation catheter manufacturing division. Changed shop floor paperwork to reflect changes to processes. Developed molding process qualification methods.

Validation Engineer, Confidential, (01/09 - 05/08/09)

Wrote changes to work instructions, flowcharts, and wrote equivalency reports supporting the launch of three new ablation products.

Validation Engineer, Confidential, (06/08 - 12/08)

Wrote process flow diagrams, qualification protocols, traceability matrices, and equipment requirement documentation for plant-wide applications. Complete gap analysis and closure for non-conformances and CAPAs to prepare for FDA inspection.

Validation Engineer, Confidential, (12/07 - 05/08)

Assisted the new product development department in constructing traceability of tests to design requirement specifications. Approved verification testing and developed validation testing methods as required. Approved test methods assuring acceptance criteria compliance. Aided in transfer of process validation to the China facility.

Design Validation Engineer, Confidential, (06/07 - 12/07)

Wrote system verification and validation protocols. Assure traceability to system design requirements. Improve verification and validation methods.

Software Quality Engineer, Confidential, (05/06 - 04/07)

Wrote the quality of verification and validation testing to ensure compliance for a new cardiac device. Wrote process risk assessment through PFMEA. Wrote design and process validation tracing to Software Design Specifications, User Requirement Specifications, and Functional Specifications. Approved design, installation, and operational qualification packages. Approved discrepancy report and subsequent retesting.

Quality Engineer, Confidential, (05/05 - 05/06)

SAP implementation validation compliance and risk assessment. Managed change control system. Helped SAP contractors write design validation protocols in Mercury TestDirector. Qualified Mercury TestDirector

Validation Engineer, Confidential, (06/99 - 09/04)

Wrote SOPs for validation library operations, disaster recovery, equipment operation, laboratory operation, electronic record retention, change control program, and factory acceptance. Perform gap analysis assessments for a pharmaceutical and medical device compliance, computer system validation for a granulation process, and OTC lines. Developed a revised tracking method to control Part 11 issues.
Wrote the traceability matrix to link the testing with the design specification . Wrote the master validation plan and qualification protocols for dehumidification systems, and vial packaging and labeling line.
Wrote and executed the protocols to validate the storage areas to be used for a new product, refrigeration system and controls, and refrigerated trailers. Acted as project manager, using MS Project, to report progress to the client. Represented the client in three regulatory inspections from prospective and current customers. Conducted a lab equipment inventory to allow the comparison of existing records and actual inventory findings. Built a database and the application used to collect and control computer system inventory and configuration changes using MS Access and Visual Basic as the application designer.

US Navy Education
Submarine Power Plant Operator and Mechanic
Business Major Coursework
Naval nuclear engineering school