EXPERIENCE

KINETICS Livermore, CA

July **** – Present

Engineering Project Manager

Management of scope, schedule, change control and budget for small to medium scale engineering projects

Development of proposals to support design-build and design-assist projects

Development of construction/engineering estimates based on conceptual and Basis of Design (BOD) and Request for Proposal (RFP) documents

Management of external engineering partners for scalability on larger projects

Procurement of engineering services and process equipment

Management of Requests for Information (RFI) and client submittals.

Facilitate the conversion of BIM process and mechanical concepts into actionable construction design documents.

Review of engineering design documentation, including drawings, bills of materials, specifications and data sheets

Conduct jobsite walks and attend pre- and post-job reviews.

INTARCIA THERAPEUTICS (Contract)

Hayward, CA

Project Engineer

November 2017 – July 2018

Lead Project Engineer for the following new Utilities Systems:

oReverse Osmosis and Deionized Water System

oWater-for-Injection System

oPure Steam Generation System

oClean-in-Place System

Development, management and maintenance of Project Work Breakdown Structure for project scheduling and phasing, including critical milestones, interdependencies and resource constraints

Management of changes to project scope/schedule, identifies potential problems, development of contingency plans

Coordination of design, construction, and startup of for new equipment/systems, and support of commissioning, qualification and change control deliverables associated with new equipment/systems

Procurement of new utility and process systems, liaison between equipment vendors and the project team, development of purchase requisitions and change orders

Development of User Requirement Specifications (URS), Functional Specifications (FS), and design specifications for GMP clean utility systems, including oversight of system integration deliverables.

Management of vendor and contractor submittals, including P&IDs, other drawings, piping and equipment specification, and project planning documentation

Change Control Record Management

Introduction of new Quality Risk Management procedures to align with the industry standard risk-based approach to Commissioning and Qualification/Validation

Maintenance of meeting minutes and an action item list to coordinate with both internal and external parties to assure the timely close out of project deliverables

Management of changes to project scope/schedule, identifies potential problems, development of contingency plans

Review of vendor/contractor design deliverables to ensure compliance with Good Engineering Practices, current Good Manufacturing Practices and safety regulations

GENENTECH/ROCHE (Contract – ValidPath)

South San Francisco/Vacaville, CA

January 2016 – December 2017

Site Lead Engineer/Business Development

Execution planning in support of client capital projects

Scoping of resource requirements and scheduling for capital projects

Processing and responding to Requests for Proposal (RFPs) for existing clients

Drafting of project proposals for GMP engineering and validation projects in support of growing business relationships with existing clients

GMP Capital Project Engineer

Leading project teams and directing execution of Commissioning and Qualification testing

Planning and execution of Commissioning and Qualification activities (FAT, SAT, Commissioning, IQ, OQ, PQ, Cleaning Validation) for commercial and clinical process equipment

Drafting and management of System Lifecycle Documentation (URS, FS, DS, Alarm Spec, RTM)

Drafting and management of Quality Risk Management Documentation (SIA, CA, PHA, RMR)

Development of Qualification/Validation strategy for new commercial and clinical Equipment; and changes to existing equipment

Trackwise Change Record (CR) Management in support of GMP capital projects

Projects

R22 Refrigerant Replacement for Temperature-Controlled Environments

New GMP Cold Room and Freezer

Lyophilizer Mass Spectrometer

New GMP Autoclaves

New Clinical Fill Line

Re-purposed QC Lab (HVAC, Purified Water)

Clinical Bulk Nitrogen Tank

AUDENTES THERAPEUTICS (Contract – Versa E&T)

South San Francisco, CA

November 2015 – January 2016

Project Engineer

Conducting impact assessments of new and existing utilities and equipment to be utilized in a repurposed biotechnology facility

Support of mammalian cell process conceptual design; development of block flow and process flow diagrams

Procurement of vendors to support the restoration of facilities and utility services for the proposed biotechnology facility, including repurposed GMP facility and repurposed process development laboratory

Troubleshooting and preparation for start-up and commissioning of GMP and non-GMP utilities. Support for assessment of current condition of existing facilities and utility systems

GENENTECH/ROCHE (Contract – Versa E&T)

Vacaville, CA

January 2015 – November 2015

Validation Engineer

Drafting and executing temperature mapping studies for temperature-controlled units

Drafting and executing qualification activities (IQ, OQ, PQ) and validation summary reports for cell culture production lab, including: owner-furnished equipment, process gases, air handlers, bio-safety cabinets, and sample booths

Support for Trackwise Change Assessment to determine impact to validated state

Drafting and executing Engineering Trace Matrices, OQ, PQ for upstream and downstream process tank Requalification including CIP and SIP

Design Qualification verification of Quality Risk Management and Lifecycle documents

CALIFORNIA PUBLIC UTILITIES COMMISSION San Francisco, CA

February 2013 – September 2014

Utilities Engineer

Conducting municipal and private utility maintenance and reliability audits

Preparation of inspection compliance reports

Performing forensic investigations and drafting written reports of electric safety incidents

Preparing for formal court proceedings before the California Public Utilities Commission

Design of reliability studies of overhead and underground electric facilities

BAXTER INTERNATIONAL (Contract – Sinpex Engineering)

Los Angeles, CA

January 2012 – February 2013

Project Engineer

Drafting of URS/FS/DS for formulation tank/ultrafiltration tank

Drafting and execution of IOQ/PQ protocols for formulation tank/ultrafiltration tank

Drafting of commissioning protocol for reverse osmosis skid

Execution of process validation for new ultrafiltration/diafiltration system and recipe

Execution of Computer System Validation (CSV) protocol for FTIR spectroscopy system

Drafting/Updating Preventive Maintenance (PM) procedures and Standard Operating Procedures (SOPs) for WFI still/loop, RO skid, distillation column, process air systems

Drafting/Updating P&IDs and PFDs for WFI Loop, RO System, Process Air Systems

Project Coordination and Project Controls for Wastewater System SCADA Upgrade

Self-Cleaning pH Design, Installation and Commissioning

Coordination/Scheduling of Construction Activities with Third-Party Contractors and In-House Stakeholders

REFERENCES

References Will Be Provided Upon Request

YUSEF COLLINS

BIOTECHNOLOGY PROJECT MANAGER/ENGINEER

OBJECTIVE

Seeking an opportunity in Project Management/Engineering or Commissioning/ Qualification/Validation in an FDA-regulated environment.

EDUCATION

B.S. Chemical Engineering

University of California

Berkeley, CA

CONTACT DETAILS

T 510-***-****

E adcjrt@r.postjobfree.com

LinkedIn https://www.linkedin.com/in/yusef-collins-458909a8

Contact this candidate