Validation Engineer Resume

This is a free Sample Validation Engineer Resume that covers objectives and tips to gets you the best Validation Engineer Jobs. The professional resume help and actions words will help you to write winning resumes. This curriculum vitae guide teach you how to write Validation Engineer resume

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Contact Information:

Full name

Present and permanent addresses

Telephone numbers

Email address

Objective:

Seeking a senior-level position to manage people, interface with customers, and work with highly technical software or hardware applications.

Career Profile:

An experienced Engineer, ability to manage large number of projects simultaneously. Always exceed deadlines and delivers on client expectations.

Education:

Bachelors of Computer Science, 2002, University of Florida

Software Skills:

• Operating Systems: UNIX (V7, SYSV, 4.3BSD, UNICOS, Solaris, BSD/OS, Linux), Windows NT.
• Passing familiarity with (used) MS-DOS, Windows 95, MacOS.
• Protocols: TCP/IP, UDP, RIP, DNS, BGP3, BGP4, OSPFv2, IS-IS, PPP, VRRP, DHCP.
• Networking media: Ethernet, FDDI, ATM, HIPPI, SONET.
• Processors: MC68000 family; Intel *86 family; Cray processors; Texas Instruments C30.
• Programming and Scripting Languages: C, sh/ksh, Perl, Perl5, Python.
• Passing familiarity with (used) PASCAL, LISP, and FORTRAN.
• Source Code Control / Configuration Management Systems: RCS, CVS, Aegis, ClearCase.
• Markup Languages: HTML, XML, DocBook.

Experience:

Abbott Diagnostics Division, Abbott Park, IL January 2005-Present

Contract Validation Engineer

• Reviewer and approver of validation deliverables (Validation Master Plan, IQ, OQ, PQ, Validation Summary)
• Help create and approve the Risk Analysis and Trace Ability matrix
• Reviewer and approver of SDLC documents (URS, SDD, SRS, Software Test Plan)
• Approve software inventory assessment, system evaluation, gap analyses and remediation for manufacturers of Medical devices (21 CFR 820) including part 11 for Electronic records and signatures
• Recommend changes in procedures, design, equipment or tailoring approaches
• Create Validation Master plan flow chart, which synthesized activity and shorten project completion time
• Review and create test cases (IQ, OQ, PQ) and completed tests to determine if expected results are achieved
• Participate as SQAE on cross-functional teams as assigned by management
• Serve as a quality resource within the project team and advise software projects on quality planning.

Quintiles Consulting, Vernon Hills, IL January 2002-January 2005

Senior Validation Specialist

• Traveled to clients in the pharmaceutical, medical device, biologic, and biotechnology industries to develop quality assurance and regulatory strategies for compliance with FDA regulations by:
• Writing Final Reports for executed Analytical Method Validation, Cleaning
• Validation, Installation Qualification (IQ), Operational Qualificationn (OQ), and Performance Qualification (PQ).
• Conducting assessments of client studies, procedures, and programs to determine compliance.
• Assisting in the development of validation programs. Developing and implementing corrective action plans to address deficiencies.
• Developing quality policies and procedures as related to validation.
• Conducting Investigations in finding root cause of product complaints and deviations and implementing corrective and preventive actions (CAPA).
• Analytical Method Master Validation Plan development.
• Reviewing and Assessing Method Validation Package as well as Method Transfer.

Johnson & Johnson, December 2001-January 2002

Contract Validation Engineer

• Developing and validating assays, test methods, and protocols for quality assurance/product support; routine statistical/data analysis and excellent technical writing/communication skills.
• Writing, modifying, reviewing, and executing validations, qualifications, and completion reports for quality assurance; familiar with standard documentation systems (TMs, MBRs, SOPs, DMRs, QATs, CAPAs, DHFs, etc.)
• Mastering a strict adherence to the regulations and guidelines of all applicable regulatory agencies, including FDA (QSR/cGMP), OSHA, ISO (including ISO14001), and Johnson and Johnson policies
• Mastering process excellence training, including Design of Experiment (DOE), Failure Mode and Effects Analysis (FMEA), Voice of the Customer (VOC), Critical to Quality (CTQ), SIPOC, Six Sigma, and Lean Thinking and Design.

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