David Truex Email & Phone Number

Dallas, Tx, Us

Dallas, Tx, Us

Various CQV projects leading a group of 3-5 CQV Professionals

Dallas, Tx, Us

CQ manager for a Biotech project in Ireland. Manage 5 CQ Suite Teams with a total CQ budget of over 30 Million Euros. Accopmplished 4 Million safe man-hours with out a lost time incident.

Commissioning and Qualification of a $180 Million greenfield manufacturing projectDuties include: - Development and Optimization of project VMP - Development of overall CQV schedule and integration into the construction schedule - Facilitate QA risk assessment - Manage the overall execution of all C&Q activities

· Validation and assessment of 18 major production systems and laboratory equipment.· The deliverables included: Development of a Commissioning Plan, Validation Plan, Resource Loaded Project Schedule, D

Provided project management oversite and technical expertise to facilitate the implementation of an ASTM E2500 validation strategy on an existing Blood Fractionation Manufacturing facility. Total scope of responsibilities was approx. $1.8M and included a subcontracted team of Cleaning Validation experts. Responsibilities included:o Providing technical oversite for all deliverables being developed and executed by the project teams.o Manage the team of Cleaning Validation experts (subcontractors) to ensure they have what they need to meet schedule expectations.o Providing regular analytical reports to the senior leadership team to track budget, earned value, confirm readiness of execution team per published schedule, and to manage resource loading as efficiently as possible due to schedule slippage.o Providing mentoring support in the areas of project management, reporting, regulatory and technical expectations to bring colleagues new to the client company up to speed on expectations and execution strategy.

Assisted with the proposed restart of to Biotech facility

• Responsible for planning and coordination all activities post commissioning to Conformance Lots, including MES testing, EMPQ coordination, CIP cycle development, Water runs and Engineering runs. • Coordinated efforts of the different process areas to allow an efficient integrated testing period and Operator proficiency.• Coordinated the testing required to ensure the manufacturing process is working smoothly prior to Conformance Lots. Test such as: Fill Line Media Fills, Cleaning Validation, Buffer Hold Studies.

• Managing the implementation and startup of Greenfield Biotech Process Manufacturing Project that includes several different process areas. Overall responsible for schedule and budget of the CQV effort. Leading a team of up to 16 agents that included projects covering:o Commissioning and Qualification of Process Equipment. Responsible for the development and approval of the Validation and Commissioning Project Plans.o Responsible for the development and execution of the Validation and Commissioning protocolso Coordinated efforts to of the different process to allow an efficient startup and testing of equipment.o Equipment installation included CIP Skids, Buffer tanks and ancillary equipment, Chromatography skids UF/DF, and Nano filtration.

• Managing the implementation and startup of clean and dirty utilities of a $1.5 billion project, that includes 10 different buildings. Leading a team of up to 16 agents that included projects covering:o Commissioning and qualification of clean utilities. Equipment included Water for Injection skids and distribution systems, purified water system skids, compressed air, compressed gas, vacuum, HVAC and an Alcohol Distillation and distribution system.o Commissioning and qualification all dirty utilities, that include emergency diesels, tower water systems, chilled water systems, waste treatment plants

project manager for a large expansion for a Medical Device Manufacturing Company. This will involve commissioning and validation of all utilities, Laboratory spaces and equipment and production lines.

Indianapolis, Indiana, Us

C&Q lead for a new Single Use Biotech Manufacturing Facility in Australia. Instrumental in the successful completion of a government inspection.

Indianapolis, Indiana, Us

Indianapolis, Indiana, Us

Client Manager at Biogen IDEC, Cambridge MA

Project at Watson Pharmaceuticals

Washington, Dc, Us

Served at the following commandsRTC San DiegoET A school Great lakesNPS OrlandoNPTU Idaho Fall Student and InstructorUSS CavallaUSS SeahorseSubmarine Squadron 2USS SpringfieldUSS ToledoUSS MaineSubmarine Developement Squadron 12Master Training Specialist