Experience

GxPartners

• United States
• Business Consulting and Services
• 1 - 100 Employee

• Sr. Validation Consultant Engineer

  • Sep 2022 - Present



RQM+

• United States
• Business Consulting and Services
• 300 - 400 Employee

• Sr. Process Validation Consultant Engineer

  • Mar 2019 - Present

  Remediation Project (Injection Molding) Remediation Project (Injection Molding)



Onebridge

• United States
• IT Services and IT Consulting
• 1 - 100 Employee

• Sr. CSV Engineer

  • Oct 2019 - Sep 2020

• Sr. CSV Engineer

  • Oct 2019 - Oct 2019



MAETRICS

• United States
• Business Consulting and Services
• 1 - 100 Employee

• Sr. Validation Engineer Consultant

  • Dec 2018 - Oct 2019



TEKWISSEN ® (Consultant at Zimmer Biomet)

• Warsaw Indiana

• Process Validation Engineer

  • Oct 2018 - Nov 2018



Onebridge

• United States
• IT Services and IT Consulting
• 1 - 100 Employee

• GLP CSV QA Auditor – Execution Lead/Specialist

  • May 2017 - Nov 2018



Looking for New Opportunities

• Indianapolis, Indiana

• Sr Quality and Compliance Consultant

  • 2018 - 2018



Sequence Inc.

• United States
• Professional Services
• 100 - 200 Employee

• Sr. Consultant, Site Lead/Team Leader

  • Jun 2016 - Apr 2017

  My responsibilities are to oversee multiple validation initiatives for equipment and utilities. Additionally, I am a Liaison between my company and the client. My responsibilities are to oversee multiple validation initiatives for equipment and utilities. Additionally, I am a Liaison between my company and the client.



MAETRICS

• United States
• Business Consulting and Services
• 1 - 100 Employee

• Analyst/Validation Engineer

  • Jul 2015 - Nov 2015

  Facilities/Utilities Qualification: • Decommissioning work of facilities equipment; Chamber replacement/qualification project: • Incubator, Freezers and Refrigerator Chambers Qualification (IOQ Thermo-mapping) • Metasys testing Facilities/Utilities Qualification: • Decommissioning work of facilities equipment; Chamber replacement/qualification project: • Incubator, Freezers and Refrigerator Chambers Qualification (IOQ Thermo-mapping) • Metasys testing



Anchor Point Technology Resources

• United States
• Information Technology & Services
• 1 - 100 Employee

• Supplier & Quality Engineer

  • Jul 2014 - Feb 2015



Maetrics®

• Indianapolis, Indiana Area

• Compliance and Quality Engineer-(Contractor at Ambu-KingSystems)

  • Dec 2013 - Jun 2014

  Performed FDA Mediation work Process validation Engineering Studies QS (Quality System) compliance review of validation documents Validation resource/consultant Performed FDA Mediation work Process validation Engineering Studies QS (Quality System) compliance review of validation documents Validation resource/consultant



Knowledge Services

• United States
• IT Services and IT Consulting
• 200 - 300 Employee

• Process Validation Engineer (Contractor at Hill-Rom Corporation)

  • Jan 2013 - Dec 2013

  Performed Special Project –Cornerstone FDA Process validation OMNIA project QS (Quality System) compliance review of validation documents Validation resource/consultant Development of Validation Plan Performed Special Project –Cornerstone FDA Process validation OMNIA project QS (Quality System) compliance review of validation documents Validation resource/consultant Development of Validation Plan



Crew Technical Services, LLC / Contractor at Eli Lilly & Co.

• Indianapolis, Indiana Area

• Computer Validation Specialist

  • Jul 2012 - Sep 2012

  Performed special project work, such as remediation of Measurex to Delta V Performance of documents evaluated and post into Regulus Ensures deliverables meet regulatory, Process Control Engineering (PCE), and the business industry expectations Evaluate quality related deliverables for accuracy, appropriate thoroughness, and completion of all appropriate Computer Systems Validation (CSV) requirements Contributes in risk assessment activities imparting feedback on validation decisions and deliverable Design/edit validation and / or qualification documentation essential for any project/change control Applies various document management techniques Show less



Cook Pharmica

• United States
• Biotechnology Research
• 1 - 100 Employee

• Validation Associate

  • Dec 2010 - Jul 2012

  Confirm Validation acceptability/intended purpose in meeting design URS-(User Requirements Specification) √ Author/write, review, approve and execute qualification validation documents, such as Test-Scripts, FAT, URS, IOQ, OQ, and PQ; also heavily involved in CAPA, RCA, Traceability Matrix, and Trackwise √ Confirm completeness of all test cases, the acceptance criteria has been met √ Author SIA’s (System Impact Assessment) and CCA’s (Component Criticality Assessment) √ Led Project executions concerning Autoclave PQ work and became a resource asset to peers √ An Approver and 2nd Person Verifier of analysis performed by other co-workers √ Confirm CGMP guidelines for equipment and retains asserts an ongoing thorough knowledge of cGMP requirements and regulatory expectations √ Using (BI’s) biological indicators in the sterilization process of Tanks, Lyophilizer, and various Autoclave loads in an aseptic environment. Show less



Eli Lilly and Company

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Sr. Validation

  • Jan 1991 - Aug 2010

  I was part of the 5500 employee restructuring that the organization underwent. The employees positions were terminated due to business needs and the company new business direction. Duties included; Reviewing and analyzing chromatography data and discussing problems with production, technical service, and engineering personnel, then making, in some cases, critical decisions that prevents SISPQ impact of the process flow; Greenbelt Six Sigma Member Led and organized the execution of validation studies for special project work, and received a Quality Award for teamwork efforts in partnering with QC ensuring the quality validation work of the Lyophilizers OQs; Performed various validation PQ studies.. √ Performed cleaning validation activities such as, tank swapping, swab site selection logic, dirty hold time, baseline visual inspection, sampling and collection analyses, CIP of buffer and product tanks of various sizes, and etc √ Underwent confine space training and LOTO √ Performed special project work to improve and make cost effective diluents used in lab analysis; √ An Approver and 2nd Person Verifier of Quality lab analysis performed by other co-workers; √ Awarded multiple (U-Awards) which is “on-the-spot-recognition” for extra teamwork contribution; √ Performed analysis of Lyspro and R-Glucagon using Agilent HPLC 1100 series, GCDS (Globe Chromatography Data System) Millennium, and Admin/Lims Data System; Also, mentor new co-workers. Show less