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
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