Computer System Validation Consultant and Process Engineering professional with experience in product formulations, process development, design and improvement, pilot and scale - up operations, facility and equipment qualifications, PC, PLC, & Software Validations, and Quality Management System Audits. Strong abilities in developing and executing Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Process Validation (PV) Protocols. Over 20 years of knowledge in manufacturing and laboratory environments (ISO, Confidential, GMP, GLP, GCP, OSHA). Extensive experience in project management, participating in regulatory audits, and implementing guidelines from CFR Parts 11, 58, 210, 211 and 820 in Pharmaceutical, Biotech and Medical Device Industries.
Confidential, Fenwick Island, DE
- Consultancy specializing in Computer Systems Validation for: Document and Content Management Systems, Environmental Monitoring Systems, Interfaces between automated systems, and Interfaces between instruments and computerized systems.
Confidential, Gaithersburg & Frederick, MD, Mountain
Data Integrity - Consultant
- I am responsible for validation of automated manufacturing equipment & processes, systems integration, and laboratory equipment configuration and qualification.
- All projects include developing and maintaining GAMP lifecycle documentation, including Computer Validation Plans, User, Functional and Design Requirements Specifications, and traceability matrices.
- Project Management and oversight of new equipment/site startup and commissioning, equipment and computer systems validation, and de-commissioning.
- I also present validation approach to Confidential and Confidential inspectors during Pre Approval Inspections (PAI) and site GMP audits.
Confidential, San Jose, CA
Validation Engineer - Consultant
- As a Consultant to the Validation Department, my roles include performing process verifications/validations, and preparing Process Failure Mode Effects Analysis and Master Validation Plans for catheters utilized in Electrophysiology, Neurovascular and Oncology procedures.
Confidential, Maryland Heights, MO
Validation Engineer - Consultant
- my roles included providing Equipment and Process Gap Assessments for Confidential, writing product and area specific Validation Master Plans, drafting and executing equipment IQs, OQs, PQs and PVs.
Confidential, Broomfield, CO
Process Validation Engineer
- my position required me to draft and execute Process Validation protocols for existing and new generic formulations for tablet and capsule manufacturing processes.
Confidential, Irvine, CA
- my position required me to interface effectively with management personnel in Engineering, Manufacturing, Regulatory Affairs, and other technical disciplines.
- I provided technical guidance to Manufacturing and Quality Control personnel.
- I also provided leadership and technical decision making for management and high level technical personnel regarding cGMP compliance, regulatory issues, validation strategy, and quality systems for projects and/or strategic activities involving up to $1,000,000 (capital/expense/revenue potentials).
- I assisted in the design and implementation of Quality Control systems for upgrading the low speed production lines to CFR Part 11 compliant automated high speed production lines, and design and execution of Validation Plans and Protocols (IQ, OQ, PQ & PV) for IV bag manufacturing.
Confidential, Mission, KS
- my role was to draft validation protocols (IQ, OQ, PQ, PV), review and recommend changes to previously drafted protocols, conduct and oversee protocol executions, optimize and validate process and instrumentation diagrams (P&Ids) discuss amendments and discrepancies with the client QA group, then compile Final Reports summarizing all validation activities.
Confidential, Los Angeles, CA
Business development consultant
- I coordinated R&D of African Naturopathic Herbs.
- I supported in the allocation and production of raw materials from the tropical rain forest.
- I coordinated all manufacturing, packaging, import and export, and shipping and receiving activities.
- I supplied the appropriate product information and materials transfer documentation to U.S. clinical sites.
Confidential, San Diego, CA
- I was responsible for doing some literature research, process design and development of food product coating and granulation process.
- I used statistical tools (DOE) for data accumulation and analysis, and I redesigned the pilot-scale lyophilization equipment used for freeze-drying active biologicals for better preservation.