Experienced in providing technical management and validation services to the medical device, biologics, and pharmaceutical industries. Team player, who works well with management, engineering, Quality, and
production personnel. Strong teamwork ability and strategic resource planning for tight timeline delivery. Strong understanding of the basics in process equipment design including piping and instrumentation, pumps, valves, filters, etc. Strong written and oral communication skills.
Technical Managment
Project Management
Capital Projects
Commissioning & Qualification
Process Validation
Facilities, Utilities, Systems, Equipment (FUSE)
Software Validation/CSV
Automation - Rockwell PLCs
SCADA, DCS, PCS, BMS
Bespoke code
Bespoke equipment
Remediation (483)
CAPA
Change Management
Risk Management
cGMP
HVAC
Clean Utilities
Aseptic Fill/Finish
Parenterals
Oral Solid Dosage
Biologics
Cell/Gene Therapy
Medical Devices
Injection Molding
Extrusion
Packaging
Serialization / Aggregation
Supply Chain
Sterilization
Temperature Mapping
Risk-Based Validation
Quality by Design (QbD)
PFMEA/DFMEA
MS Project
Minitab
DeltaV
Trackwise
Maximo CMMS
Kneat
Siemens S7
ISO
USP
21 CFR 210, 211, 820
21 CFR Part 11
GAMP5More...
Keiana Williams
Senior Financial Analyst
Verified
Keiana Williams is a seasoned finance professional with extensive experience in financial analysis, as a Senior Financial Analyst. She holds a degree in Accounting and Finance and has developed her career in various prestigious Fortune 500 companies. Keiana excels in developing financial models, conducting benchmark studies, and performing complex financial analysis to support strategic decision-making. Her analytical skills, coupled with her deep understanding of the Finance, enable her to provide valuable insights and recommendations for business growth. With her commitment to accuracy and efficiency, Keiana plays a crucial role in her team by providing robust financial forecasts and contributing to financial planning and strategy. Over the years, she has built a reputation for her excellent problem-solving skills, attention to detail, and ability to work under pressure. She is also committed to continuous learning to stay abreast of the latest trends and developments in the Finance and IT arenas.More...