Wilfredo Rivera

Wilfredo Rivera, PE, CPP

Over twenty years of increasing responsibilities in project management, engineering, construction, and plant operations, supervision and maintenance experience. Experience includes medical device, chemical, pharmaceutical, biotech, and consumer products in the manufacture of ethical and OTC products, vaccines, medical devices, liquids, solid dosages, suppositories, ointments, capsule filling, aseptic filling of vials and syringes, packaging technology, material handling systems, bar coding, e-pedigree, laser marking equipment, machine vision technology, and non-destructive leak detection systems. Project management experience has included financial performance, coordination of design disciplines, supervision of design teams, budgeting and scheduling, progress monitoring, and working with international corporations and vendors. Project engineering responsibilities include development and preparation of detailed equipment layouts, equipment design calculations, specifications and data sheets, reviewing equipment designs, overseeing factory acceptance runs, and interfacing with vendors. Manufacturing experience includes design and installation of systems for sterile filling and packaging, medical device assembly, product sterilization, solids handling/weighing/feeding, and automated tablet, liquid, powder, capsule, and packaging operations.

Professional Experience

URS Washington Division, Princeton, NJ. Senior Project Manager (Mar 2005 – May 2009)

GlaxoSmithKline Biologicals, Marietta, PA, Project Manager Fill/Finish Lyophilization Facility Renovation. Lead engineering, permitting, procurement, construction management, commissioning, calibration, and validation activities in the renovation of the existing facility. Facility designed for formulation of vaccines. Operations include clean utilities, formulation, sterilization, RABS, vial filling, component and parts preparation, cold rooms, decontamination, lyophilization, capping and automatic inspection of vials, sanitization, decontamination, and biowaste inactivation. Managed documentation for, Permits, Insurance Certifications, Construction Documents; Value Engineering, HAZOP Reviews, Vendor Drawing submittals, Document Control, Cost and Schedule, Change Management, and Requests for Information.

Amgen Manufacturing Limited, Juncos, PR, Project Manager. Lead engineering, procurement, construction and commissioning of new facilities for inspection of vials using machine vision, and the automation of the BD Flange assembly and cartoning for syringes on fast track design/build expansion. Managed the Permits, Insurance Certifications, Construction Documents, Cost and Schedule, Change Management, and Requests for Information.

Mustang Tampa. Inc., Philadelphia, PA, Director, Engineering and Technology. (Jun 2002 – Mar 2005)

Wyeth, Pearl River, NY. Project Manager. Managed resources for authoring/executing SAT and IOQ protocols to commission and validate equipment on this new aseptic vial filling line consisting of an Isolator/VHP, Vial Washer, Depyrogenation Tunnel, Filler/Stopper, Lyophilizer Auto Loader and Lyophilizer, Capper and External Vial Washer.

GlaxoSmithKline, Clifton, NJ, Project Manager. Engage design firm to develop Construction Documents, Specifications, Permits, Bid Packages, Cost Estimate, Operating and Maintenance Costs and Project Schedule for Wastewater Treatment Plant with capability to store process wastewater and control discharge pH levels.

Washington Group International, Inc., Cleveland, OH. (Aug 1995 – Jun 2002)

Merck & Co., West Point, PA, Project Engineer. Assisted client managing construction activities for vaccine production and packaging facility, consisting of formulation, sterile filling, and packaging systems. Coordinated equipment specifications, bid packages, vendor selection, and technical design reviews. Coordinated area inspections, walk downs, punch lists, design change notices. Performed FATs, and managed manufacturer’s technical support to facilitate IOQs, and PQs.

Pharmacia, Barceloneta, PR Project Manager. Installation and startup of vial packaging line with inspection machines, labeler, thermoformer, cartoner, checkweigher, bundler, and case sealer and shipper label printer/applicator. Managed disciplines in development of Master Site Plan for the facility, computer model to identify capacity constraints and calculate supply requirements for the utility systems based on future increases in facility square footage.

Gliatech, Inc., Solon, OH, Project Engineer. Optimized operating parameters for medical device manufacturing process using mixers, eductor valves, ion exchange column, filtration, liquid filling and heat seal packaging.

American Pharmaceutical Partners, Inc., Melrose Park, IL. Project Manager. Managed disciplines on fast track project to design/build expansion of 11M SF for two lyophilizers, compounding room (H4 Occupancy), a Class 100 filling, and capping line.

Johnson & Johnson Medical, Inc., CT. Project Engineer. Reviewed layout and packaging operations in the redesign of the catheter manufacturing process to optimize efficiency and reduce space requirements by consolidating operations and establishing flexible work cells.

Regeneron Pharmaceuticals, Inc., Rensselaer, NY. Project Manager. Guidance with respect to cGMPs in fermentation and purification processes. Action plans to address manufacturing deviations prior to Pre-Approval Inspection. Developed strategy for manufacturing team to perform a gap analysis in level of cGMP compliance, and training.

Fort Dodge Animal Health, Fort Dodge, IA/Brazil. Project Manager. Managed validation and startup activities for a sterile liquid filling line. Activities for this project required interfacing the validation effort writing protocols for IQ/OQ and PQ for the filling process equipment, HVAC systems, building/architectural modifications, and media fills.

The Geon Co., Pedricktown, NJ. Lead Engineer. Analyze storage/material handling of resins manufacturing process to define improvements to reduce cycle times in loading/unloading of materials into silos, trucks, and railcars. Defined solutions for segregation of fines, material handling, reduction in cycle times to load, unload trucks and railcars, and temperature and humidity.

Matrix Essentials, Solon, OH. Project Engineer. Manage disciplines to design and develop equipment specifications and layouts for healthcare products filling and packaging operations.

United States Department of Defense, Ukraine. Lead Engineer. Determine process capacity to neutralize ICBM Soviet SS-18 missiles utilizing stand alone mobile incinerators. Feasibility study to determine if existing Water Treatment plant should be modernized for use in the neutralization process.

MedImmune, Inc, Cleveland, OH, Lead Engineer. Provided conceptual layout and prepared specifications and technical purchasing documents for aseptic bottle filling and blood plasma thaw/cut operations.

SmithKline Beecham Pharmaceuticals Co. Franklin Plaza, PA / Cidra, PR (Oct 1989 – Aug 1995)

Senior Manufacturing Equipment Engineer. Maximize efficiency, reduce costs, and improve product quality. Developed designs and specifications for equipment systems, reviewed bids, recommended awards, and oversaw fabrication, installation, and startup. Assisted startup and validation of contract manufacturing and packaging.

SKF, Cidra, Puerto Rico. Packaging Technical Advisor. Manage resources for packaging process startup. Implement technology plan for the automation, replacement, and upgrading of existing packaging equipment. Standardize/consolidate package presentations to facilitate automation, improve efficiency, and reduce costs. Prepared authorizations, specifications, negotiated pricing, terms and conditions with suppliers, coordinated the installation and operational qualifications for projects.

SKF, Cidra, PR, Manufacturing Engineer. Led team in operational excellence projects for multiple products dosage formats, packaging operations, and warehouse operations. Evaluated new technology for implementation. Developed component sheets, material specifications, coordinated stability testing and set-downs, selected alternate materials for primary and secondary packaging components, standardized components and sources to reduce unit cost, coordinated equipment selection, installation, qualification, and validation.

Mova Pharmaceuticals Corporation, Caguas, PR, Packaging Supervisor. (Jul 1987 – Oct 1989)
Responsible for effective communication and management of contract packaging operations and effective utilization of resources to meet production requirements. Coordinated the selection, installation, qualification, and validation of packaging equipment; started up new operations; provided cost analysis for potential manufacturing/packaging contracts.

Searle & Co., Caguas, PR, Packaging Supervisor. (May 1984 – Jul 1987)
Led team in the accomplishment of production requirements, cost savings, and continuous compliance with cGMPs. Provided industrial engineering support to the packaging department. Developed and implemented cost reduction and efficiency improvement initiatives. Procurement/Installation of blister packaging.

Travenol Laboratories, Aibonito, PR, Industrial Engineer. (Feb 1983 – May 1984)
Manage Productivity Improvement Program tracking system to follow actual cost savings. Performed time and motion studies, capacity analyses, implemented cost reduction measures, and evaluated indirect labor requirements. Developed equipment specifications and design concepts for the automation of IV set assemblies.

EDUCATION

B.S., Industrial Engineering, University of Puerto Rico

PROFESSIONAL REGISTRATIONS PROFESSIONAL AFFILIATIONS
• Licensed Professional Engineer in Ohio and Puerto Rico
• Certified Packaging Professional (CPP) – Lifetime Certification
• IRCA – Certified ISO 9000 Auditor
• Institute of Packaging Professionals (IoPP)
• College of Engineers and Surveyors - CIAPR
• International Society of Pharmaceutical Engineers (ISPE) - (also presented for the ISPE Great Lakes Chapter an Introduction to ISO 9000)