SUMMARY:

• A Senior Software Quality Engineer position in the Medical Device/Pharmaceutical Company.
• 17 years plus of professional experience.
• 17 Years of hands - on Computer System Validation, Manufacturing Equipment Installation and Qualification, Test Method Validation, R&D, 21 CFR Part 11/ Part 820 Regulations, ISO 14971, and GAMP5.
• Worked with many Automation and process systems like Track and Trace DCS, PLC, HMI, custom software systems etc. for unit operations like compounding, batching, cleaning, freeze drying, SIP, filling, packaging.
• 7 years of lead/project management experience for computer system validation.
• Interfaced directly with FDA during audits as a CSV subject matter expert.
• 2 years of Enterprise Resource Planning (ERP) software validations.
• 5 years of experiences in Remediation projects with extensive validation/QA/QE experience in a plant environment.
• Handled complete life cycle including IQ/OQ/PQ protocol creation, testing root cause analysis of system software errors after release to production, writing non-conformance and investigation reports, corrective (change control) and preventive action (CAPA), risk assessment, PFMEAs, etc.
• 2 years of hands-on programming experience with PLC/SCADA/DCS etc.
• 6 Years of experience in GxP Sterile Aseptic pharmaceutical Packaging with Bosch Packaging and Confidential Laboratories.
• 10 years of experience in GxP Medical Devices industry.
• Excellent team player.
• Works well with management, vendors and production maintenance personnel.
• Open to relocate and travel as required.

COMPUTER SKILLS:

PLC AB Platform: Embedded Software, Wonderware, InTouch HMI, NI LabView, Visual Basics, MSVC++, Borland C++, C, Java-script, HTML, Pascal, Basics, Fortran, Unix, Rational Visual Test, InstallShield, MiniTab Microsoft Office 2010 Word, Excel, Access, Outlook, Visio, Project, etc.

WORK EXPERIENCE:

Confidential

Validation Manager

Responsibilities:

• Manage an equipment validation project includes purchasing, commissioning, installing, and qualifying a liquid-filling packaging line for production use
• Provide leadership to the validation team to develop, review, and approve document all phases of software and equipment designs, commissioning, and qualifications.
• Communicate and resolve issues with vendors
• Report weekly progress to management.

Confidential, Plymouth, MN

Sr. Technical Services Engineer

Responsibilities:

• Consult on compliant and regulation issues related to CFR part 11 and packaging system technology.
• Develop, review, approve, and execute packaging equipment IQ/OQ/PQ protocols, cleaning validation protocols, Track and Trace (Serialization) validation protocols, Master Validation Plans, Test Matrices, Test Method Validation (TMV), and generate technical reports.
• Develop, review and approve manufacturing SOPs, processes, PFMEA and operators materials
• Develop review and approve SDLC and GxP documents such as URS, SRS, DS, Traceability Matrices, and Risk Analysis.
• Manage validation and equipment installation, testing and qualification projects.

Confidential

Sr. Computer Validation Engineer

Responsibilities:

• Consult on compliant and regulation issues related to CFR Part 11/820.
• Assess gaps and develop legacy SDLC documents such as URS, SRS, DS, Traceability Matrices, and Risk Analysis.
• Develop, review, approve and execute software test and test method validation protocols, and generate technical reports for embedded Control System.
• Lead and execute CSV activities on SW validation testing.

Confidential, New Brighton, MN

Sr. Computer Validation Engineer

Responsibilities:

• Develop, execute software test protocols, and generate technical reports.
• Develop, review and approve SDLC documents such as SOPs, Flowcharts, URS, SRS, DS, Traceability Matrices, and Risk Analysis.
• Lead and execute CSV activities on SW validation testing.

Confidential, Eden Prairie, MN

Sr. System Validation/Quality Engineer

Responsibilities:

• Review and assess for gaps between existing documents and regulatory standards (CFR Part 11/820) on a Remediation Project
• Develop SDLC and compliant documents such as URS, SRS, DS, Traceability Matrices, FMECA and Risk Analysis, and Manufacturing SOPs and Processes
• Lead and execute CSV activities on SW validation testing.
• Develop, review, approve and execute software tests, equipment IQ/OQ/PQ and TMV protocols, and generate technical reports.

Confidential, Queensbury, NY

Sr. Computer Validation Engineer

Responsibilities:

• Develop, execute software test protocols, and generate technical reports for ERP System.
• Develop, review, and approve SDLC documents such as SOPs, Flowcharts, URS, SRS, DS, Traceability Matrices, and Risk Analysis.
• Lead and execute CSV activities on SW validation testing.
• Collaborate with cross-functional teams to develop system control and management software and documents.

Confidential, Portage, MI

Sr. Computer Validation Engineer

Responsibilities:

• Develop, review and execute software test protocols, and generate technical reports and ECO’s.
• Develop SDLC and GxP documents such as URS, SRS, DS, Traceability Matrices, PFMEA and Risk Analysis.
• Develop test fixtures, tools, and setup test equipment (NI LabView platform).
• Lead and execute CSV activities on SW validation testing.
• Collaborate with cross-functional team to develop automated control software and documents.

Confidential, St. Paul, MN

Sr. System Validation and Quality Engineer

Responsibilities:

• Manage product transfers from R&D to GxP Manufacturing and from one facility to another.
• Develop and execute Transfer Plans, Master Validation Test Plans, and Manufacturing Plans.
• Review and assess for non-compliant documents and manufacturing processes and then update.
• Develop, execute equipment IQ/OQ/PQ and TMV protocols, and generate technical reports and ECO’s.
• Develop test fixtures, tools, and setup test equipment for new products (NI LabView platform).
• Develop and validate assembly and test procedures and robotic functions.
• Develop and improve manufacturing assembly processes, and PFMEA.
• Evaluate and recommend new test equipment for improvement in manufacturing processes.
• Lead and execute CSV activities on new products.
• Collaborate with cross-functional team to launch new products.
• Work with vendors to resolve quality issues related to hardware manufacturing.

Confidential, Brooklyn Park, MN

Sr. Software Validation and Quality Engineer

Responsibilities:

• Develop User Requirement Specification, Functional Specifications, Software Design Specifications, Computer System Validation Test Plans, Risk Analysis, Traceability Matrices, and other Software Development Life Cycle documentation for GxP Pharmaceutical Customers.
• Develop, review, approve and execute Computer System and Software Validation test protocols for PLC Automation Control Systems, robotics, SCADA systems, and generate technical reports.
• Develop, review, approve and execute Equipment Commissioning (FAT, SAT) and Qualification (IQ/OQ/PQ) Test Protocols, CIP, SIP on pharmaceutical filling machines at various Pharmaceutical Customers’ sites.
• Develop validation strategies and master test plan for various Pharmaceutical Customers’ projects.
• Perform compliance assessments (CFR Part 11 and GAMP5) and risk analysis of computerized/automation systems.
• Conduct staff classes at Pharmaceutical Customers’ sites including classroom presentation and hands-on.
• Manage validation activities and projects at Pharmaceutical Customers’ sites which include supervising and coordinating resources, scheduling, budgeting, monitoring progress, and reporting to managements.
• Collaborate with Customers to design and upgrade new control and electrical systems using new advanced technology and automation (PLC, SCADA, and BAS)
• Develop and implement Corporate Infrastructure for business management system (SAP), new Standard Operation Procedures (SOPs).

Confidential, Maple Grove, MN

Automation System and Software Test Engineer

Responsibilities:

• Collaborate with Customers and Design Engineers to develop GxP Equipment Specifications, Software Requirement Specifications, Computer System Validation Tests (PLC, LabView, robotics, and SCADA), and Software Configuration and Installation documents.
• Write, review, execute, and report of Computer System Validation protocols and Equipment Qualification protocols (IQ/OQ/PQ) using PDM (Electronic Signatures)
• Manage and perform validation projects in support of equipment, product, and process validation.
• Select or design test equipment as required accomplishing compliant responsibilities.
• Conduct software compliant assessments (CFR Part 11/820) and risk analysis including FMECA.
• Generate and review Validation SOPs and suggest changes for improvement when necessary.
• Execute backup system software.
• Assist rewrite Design Quality Control policy.

Confidential, Plymouth, MN

Software Test Engineer

Responsibilities:

• Upgrade firmware and support sustaining medical software products.
• Develop Software Test Plans (STP) and protocols (both manual and automated using scripts) Software Requirement Specifications (SRS), Software Development Plan (SDP), Software Design Specifications (SDS), Customer Requirement Specifications (CRS), Software Configuration Control (SCC), and software manuals.
• Develop test scripts and execute V/V software tests both automated (Rational Visual Test 6.0) and manual.
• Develop technical reports; prepare Engineering Change Order and documentation for software releases.
• Develop installation media using Install Shields software.
• Project leader for several medical software products including development and testing.