Summary
Overview
Work History
Education
Skills
Certification
Timeline
Generic

Lanet Grantham

St. Louis,MO

Summary

Manufacturing Engineer with a track record of successfully completing demanding projects on time. Detail-oriented and highly organized, excelling in process optimization and problem-solving. Recognized for implementing innovative resolutions to complex situations.

Overview

22
22
years of professional experience
1
1
Certification

Work History

Manufacturing Engineer-Surgical

Kelly Services-Bausch & Lomb
Saint Louis, MO
03.2024 - 09.2024
  • Analyzed existing medical device infrastructure and identified areas for improvement.
  • Developed detailed project plans for medical device implementations.
  • Evaluated vendor proposals and negotiated contracts for the purchase of new medical devices.
  • Documented user requirements, processes, procedures, and workflows related to the implementation of new medical devices.
  • Developed strategies for integrating existing IT systems with newly-deployed medical devices.
  • Documented all engineering activities according to established procedures.
  • Participated in team meetings to discuss project progress updates.
  • Used computer systems and drafting equipment to create and outline designs of components and tools.
  • Created accurate project specifications, documenting in technical manuals.
  • Determined design criteria or specifications.

Principal Consultant I

CAI-Eli Lilly
Saint Louis, MO
02.2024 - 04.2024
  • Assisted in the development of new products by providing guidance regarding design controls and best practices for ensuring high levels of quality.
  • Provided technical support to customers regarding product design issues or concerns about product quality.
  • Crafted project quality plans to meet quality assurance and quality control expectations.
  • Formulated and updated organizational quality standards by creating documents outlining quality procedures.
  • Collaborated with various departmental and business decision-makers to establish quality initiatives and boost awareness.
  • Monitored testing procedures to meet established item specifications, standard test methods or protocols.

Principal Consultant I

CAI-MSD
Frisoythe, Germany
01.2024 - 01.2024
  • Conducted research and analysis on complex business problems and prepared reports for stakeholders.
  • Led workshops with clients to identify their needs and develop appropriate solutions.
  • Developed training programs for staff members regarding new technologies or methods.
  • Drafted proposals outlining project scope, timeline, deliverables and cost estimates.
  • Identified risks associated with projects before making decisions about implementation.
  • Analyzed financial statements to provide insights into areas of improvement or growth opportunities.
  • Implemented quality assurance standards in order to ensure that all deliverables meet customer requirements.
  • Evaluated internal systems and prepared training initiatives to mitigate ongoing problems.
  • Assessed employees through on-site observation and interviews to determine strengths and weaknesses in work performance, methods and team functions.
  • Identified risks and assessed potential impact, consulting with clients to prepare mitigation plan.
  • Prepared accurate and concise reports, conveying progress, issues and solutions.

Validation Engineer

CAI-ThermoFisher
St. Louis, MO
01.2022 - 12.2023
  • Development and execution of engineering documents, including Equipment Specification, User Requirements Specification, Factory Acceptance Test, System Impact Assessment, and Component Impact Assessment associated with the expansion of facilities.
  • Analyze validation test data to determine whether systems or processes have met validation criteria or to identify root causes of production problems.
  • Formulated validation master plans, process flow diagrams, and standard operating procedures
  • Identified and resolved deviations from established product or process standards
  • Developed validation protocols for process equipment and systems.
  • Authored and executed qualification protocols for clean utilities, HVAC, and manufacturing processes.
  • Analyzed data to ensure compliance with FDA regulations.

QC Equipment Coordinator

Mindlance
St. Louis, MO
06.2021 - 12.2021
  • Schedule all equipment services, coordinating with the contractor, and service provider of the metrology group, including but not limited to PM schedules, and calibration
  • Asset management – commissioning of new QC (Quality Control) equipment, removal and/or disposal of all decommissioned QC-owned equipment
  • Process service contact and renewals through AIRBA
  • Finalized equipment maintenance using SAP (Statistical Analysis Plan) software
  • Review the calibration/verification or PM data to ensure calibration of the equipment according to predetermined schedules and procedures
  • Execute IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) Validation requirements
  • Manage multiple projects
  • Capital Appropriation Request

Testing Supervisor

Creative Testing Solutions
St. Louis, MO
08.2019 - 04.2021
  • Lead FDA (Food and Drug Administration) inspections and Audits
  • Experience with problem-solving tools (8D, 5-whys, cause, and effect
  • Develop realistic solutions to meet customer needs and solve problems
  • Strong Root Cause / Corrective Action skills
  • Managed noncompliance activities using Track-wise Software
  • Opened and Managed Change Controls
  • Managed staffing levels and workflow mapping
  • Managed and Mentored 25 direct report permanent and contract workers
  • Create schedule plans for projects -punchline review

Lead Technical Specialist

Creative Testing Solutions
St. Louis, MO
02.2016 - 08.2019
  • Prioritized, organized, and managed a high-volume workload efficiently Interpreting test results, including identification and correction of discrepancies
  • Maintained effective communication with customers ensuring quality customer service and proper specimen testing protocol
  • Proactively identified potential compliance concerns, effectively mitigating the need for problem escalation
  • Devised and executed a routine biological sample testing program, including proper reagent preparation, pre-qualification, and quality assurance, ensuring prompt review and release of test results

Quality Control Instructor

American Red Cross
St. Louis, MO
10.2011 - 02.2016
  • Adhered to a strict, time-sensitive training schedule across three production shifts to maintain employee competency compliance and regulation
  • Maintained detailed competency assessments and staff training documentation records
  • Conducted periodic retraining where quality or performance issues were noted and required system or process changes

Quality Control Manufacturing Technologist

American Red Cross
St. Louis, MO
04.2009 - 10.2011
  • Performed Preventative Maintain and Calibrations of the BacT Alert System
  • Trained staff on proper aseptic technique
  • Managed recalls of reactive platelet products
  • Performed automated and manual test procedures on blood samples to ensure the safety, potency, and purity of the blood supply
  • Aided in the identification of potential problems and errors, troubleshooting, and implementing corrective actions

Medical Technologist

Quest Diagnostics
St. Louis, MO
08.2002 - 05.2007
  • Demonstrated the ability to communicate test results effectively with physicians and supporting staff providing exemplary customer service
  • Evaluated quality control within the laboratory using standard laboratory tests and measurement controls, maintaining compliance with CLIA, OSHA (Occupational Safety & Health Administration), safety, and risk management guidelines
  • Process Improvement Achievement - Implemented a visual detection sample testing system, reducing turn-around time delays, and work redundancy by 80%

Education

Bachelor of Science - Biology

Freed-Hardeman University
01.2000

Skills

  • Asset management
  • ISO 9001
  • Microsoft Excel
  • Minitab
  • Calibration
  • Quality management
  • SharePoint
  • Root cause analysis
  • SAP
  • Lean
  • Six Sigma
  • Lean manufacturing
  • 5S
  • Aseptic technique
  • Process improvement
  • CGMP (Current Good Manufacturing Practice)
  • Product development
  • Technical writing
  • Supervising experience
  • Microsoft Access
  • FDA regulations
  • Quantitative Analysis Expertise
  • Risk Management Analysis
  • Risk Analysis Expertise
  • Implementation of Design Controls
  • Clinical Laboratory Proficiency
  • Quality Management Systems
  • Change Management Expertise
  • Prioritization and Scheduling
  • Quality Assurance
  • Skilled in Microsoft Office
  • Internal Audit Management
  • Skilled in Visio Software
  • ERP Software Proficiency
  • Process Improvement
  • Production Methodologies

Certification

Kneat End Power User

Timeline

Manufacturing Engineer-Surgical

Kelly Services-Bausch & Lomb
03.2024 - 09.2024

Principal Consultant I

CAI-Eli Lilly
02.2024 - 04.2024

Principal Consultant I

CAI-MSD
01.2024 - 01.2024

Validation Engineer

CAI-ThermoFisher
01.2022 - 12.2023

QC Equipment Coordinator

Mindlance
06.2021 - 12.2021

Testing Supervisor

Creative Testing Solutions
08.2019 - 04.2021

Lead Technical Specialist

Creative Testing Solutions
02.2016 - 08.2019

Quality Control Instructor

American Red Cross
10.2011 - 02.2016

Quality Control Manufacturing Technologist

American Red Cross
04.2009 - 10.2011

Medical Technologist

Quest Diagnostics
08.2002 - 05.2007

Bachelor of Science - Biology

Freed-Hardeman University

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Lanet Grantham