Engineering, Project Management, Manufacturing and Quality Assurance

KOREDE JOHNSON P.Eng., PMP.

Phone: 905-***-****/ Cell: 289-***-****

Address: ** ****** ***** ********, *******, L9C 7T5

Email: ********@*****.***

OBJECTIVE: Process engineer seeks a role that utilizes his Manufacturing, Process Engineering, Operations,

Project Management, Quality Assurance, Packaging, HSE experience, and leadership skills.

TECHNICAL SKILLS SUMMARY

Extensive experience in EPC and Operations environments and Executing Process Improvement Projects. Managed equipment installation, commissioning and qualification projects.

Project management experience in leading and directing cross-functional teams to deliver capital projects.

Managed engineering projects including estimating costs, sourcing, identifying, specifying, purchasing and installing equipment, and design & modification of existing or new facilities to meet safety, environment and quality requirements.

Developed and established preventive maintenance program for manufacturing equipment and storage facilities. Worked with RCA (Reliability Centered Maintenance) and TPM (Total Predictive maintenance).

Experienced in Developing and Maintaining Policies and Procedures to facilitate and ensure compliance with legislative and corporate quality requirements for equipment maintenance and new product launch.

Hands on experience in Managing Engineering Change Process to ensure that product and equipment changes are communicated internally and executed in a timely and safe manner.

Develop and deliver progress reports, safety proposals and quality requirements, communication and presentation documents utilizing: SAP, Track wise, MS-Project, MS-Office. Report and follow up on KPI’s.

Excellent verbal and written communication skills sharpened through protocol and technical report preparation.Outstanding problem solver and capable decision maker developed through diverse work experiences. Experienced in establishing and maintaining Risk Management processes.

Experienced in executing process design, process optimization and performance qualification projects.

Sound knowledge of PMBOK Guidelines, GMP and understanding of OH&S regulatory requirements, ANSI, ISO14001, ISO9001, ISO 31000, TQM, 6-Sigma guidelines.

Good knowledge of environmental monitoring processes for project/product impact. Experience with PLC/HMI/automation equipment, authoring validation protocols, hands on experience in pharmaceutical and manufacturing industries. Familiar with FDA and Health Canada & ICH guidelines.

EMPLOYMENT HISTORY

Apollo Health and Beauty Inc., ON, Canada. May 2014 – March 2015

Product Development Manager

Reporting to the Director of Operations, manage all new product launch and quality assurance processes; manage PMO office. In charge of all new product development procedures, new process design and installation of equipment for quality assurance and product speed to market.

Create and managed project management office and interdepartmental/internal communication processes.

Create and managed product development, equipment upgrade and incoming quality control teams.

Initiate process optimization procedures for bulk batching, packaging components selection/testing and incoming quality control with Advanced Product Quality Planning (APQP) to meet customer deadlines.

Provide technical reference/support for change control, deviation and CAPA processes for new products.

Provide technical reference/support for engineering, maintenance and production processes.

Ensure C&Q responsibilities and leadership for major critical capital projects. Develop and maintain strong leadership with customers, suppliers and contractors both internally and in the market place to manage timeline. Optimize productivity in order to complete projects on time and within budget.

Multi-task, co-ordinate and prioritize engineering project activities to meet the changing and growing need of the business. Communication of issues related to capital project execution to senior management

Direct and monitor external (contractor) workforce for construction phases of engineering capital projects to assure projects are implemented per the established scope, on time, and within budget. Assure compliance with all Good Manufacturing Practices required documentation for all installed equipment. Performed appropriate project Risk/Award analysis to obtain approvals.

Create and assist in the creation of detailed bid for new business and products launches for private label customers and packages for contractors & equipment vendors. Select and direct construction contractors /equipment vendors and packaging design /supply vendors. Project scope: $3.8M.

Sanofi Pasteur Ltd., ON, Canada. May 2011 – May 2014

Professional - Formulation, Filling & Packaging

Reporting to the Deputy Director (Process industrialization) Manufacturing Technology, responsible for Major Capital Projects, interfaced with project teams to develop the overall C&Q Phase Project Plan & Schedule which includes commissioning, installation & operational qualification and performance qualification of product and non-product dependant systems (facility, utilities). Project scope: $3.3M.

Lead Filling & Packaging capital project team for facilities and equipment upgrades. Participated in developing and implementing site commissioning plans for facility systems, process systems and equipment; participate in identifying critical parameters/instrumentation, and critical functions of systems; Develop test functions to challenge the facility and process systems operating capabilities.

Coordinate construction walk-through, and develop and maintain deficiency lists (punch lists and exceptions lists). Audit project documentation for turnover to internal customer to ensure compliance. Ensured project safety and implemented all required training.

Established and maintained Engineering Turn-Over Documentation Library. Prepared all start-up documentation for turnover to Production and Facility Maintenance, and other customer groups.

Lead investigation to optimize the filling, labelling and packaging processes, facilities and equipment. Initiate and implement corrective and preventive actions for Labeling and Packaging process improvement. Member Global Right First Time Shop Floor Excellence project team; design and implement PC/APC boards for process performance monitoring and improvement. Performed root cause analysis for non-conformances relating to facility and equipment failures.

Resolved customer complaints through process improvement and supported Filling and Packaging Deputy Directors in daily operations/project management tasks as assigned, write and review of Standard Operating Procedures and performed Quality Assurance activities. Submitted Change Control Requests (CCRs) and take actions to implement and document changes. Supported internal, corporate and regulatory agency audits and completed Health Safety and Environment projects.

Deb Worldwide Healthcare Inc., ON, Canada. Aug 2008 -Dec 2010

QA-Validation/Qualification Specialist

Executed process and product validation project for Pharmaceutical products formulation and packaging. Conducted stability rooms’ design, installation and qualification. Completed temperature mapping project for healthcare products and raw materials storage environment. Performed vendor qualification processes as per GMP, FDA, ICH and Health Canada requirements for facility area involving; batch mixing, products filling and packaging, raw materials and finished products storage. Lead Validation/Qualification project team. Experience with PLC/HMI/automation equipment for filling and packaging, authoring validation protocols and SOPs, experience in pharmaceutical and cosmetics manufacturing processes.

Co-ordinate quality assurance projects for process improvement and products standards in Healthcare products manufacturing operation. Investigate and correct inconsistency (out of limit) in actual bulk product yield during bulk batch manufacturing process. Propose and implement solution to address material loss and bring yield within limit of 95% to 105% as per specification.

Completed process upgrade with projects for equipment sizing, procurement, installation, commissioning, qualification, calibration and safety audit: Manufacturing equipment (mixing machines, baffled batch manufacturing tanks, air strippers, ventilators, HPLC, Depyrogenation oven), plant support equipment (compressed air systems, pumps, valves and flow taps, stability /temperature controlled rooms, reverse osmosis water systems, total organic carbon analyzers), and pharmaceutical packaging and labeling machines. Successful completion of projects increased production and profit by 285% of estimated value.

Developed and completed URS, IQ, OQ and PQ for Stability rooms, 5000litre baffled tanks and mixers, Converted liquid loading process from Volume(L) to Mass (kg), Filling & Packaging lines upgrade, Retrofitted HVAC system. Member joint Health and Safety Committee.

Perform Quality Assurance audit and process optimization projects to reduced annual customer complaints, from 7% to 0.05%. Performed validation and qualification per CFR 11 and documentation.

Project scope: $1.9M

Project/Quality Engineer, CAST Engineering Ltd, Johannesburg, South Africa Aug 2007 – Jun 2008

Developed and established preventive maintenance program for bulk petroleum products Depot, in cooperation with Engineering, Maintenance, Quality and Production departments. Design and Coordinate Health Safety and Environment management system. Reduce maintenance cost for bulk petroleum facility by 35% of actual budget with design and implementation of preventive maintenance process. Project Scope; $120K

Completed equipment sizing, procurement, installation, commissioning, management (EPCM) and qualification projects for; Petroleum products bulk storage facility (Storage tanks and support structures, pipes, valves, pumps etc.). Used ANSI/API and ISO standards in equipment selection and installation of Spill containment structures and equipment. Used ISO14001 and ANSI/API standards in selecting and installation of loading gantry and ancillary parts. Used ANSI/API and ISO/CT 92 standards in procuring Fire and safety equipment. Project scope; $450K.

Project Engineer/Safety Consultant, Seanuts Inspection Services Ltd, Lagos, Nigeria Feb 2004 - Jul 2007

Designed safety case for petroleum products bulk storage facilities. Conducted safety inspection of products in bulk storage facilities. Completed risk assessment projects and prepared documents for natural gas storage and transport vessels. Co-ordinate operation staff and sub contractors in downstream petroleum projects and operations. Completed Environmental impact assessment and waste treatment and disposal projects for downstream petroleum operations. Supervised internal and external team for construction and commissioning of bulk petroleum storage facility. Project Scope; $500K

Completed health, safety and environment documentation project (Based on ISO14001 and ISO9001) for Shell Petroleum Development company’s Associated Gas gathering project; Organized information and cost gathering, interview vendors and request quotes/bids, performed review of project design, equipment selection, operation and control philosophy, coordinate vendor selection process, write summary report and made recommendations based on API and Department of Petroleum Resources-Nigeria (DPR) Standards.

Assistant Manager - Special projects, Em-International Systems Ltd, Lagos Nigeria Apr 2001 - Jan 2004

Managed Facilities transport and logistics projects for telecoms infrastructure and customer care centre design built and operate.

Completed $1.2M engineering infrastructure turn key projects aimed at implementing strategic business decisions. Completed Green fields and Brown fields telecommunication base station installation projects.

Deployed three (3) base stations and a CDMA-1x switch for existing fixed wireless telephone operation. Lead project team, acquired and visit green and existing fields/sites. Review infrastructure and equipment design for integrity, specifications and performance as per International Telecommunication Union –ITU requirements. Perform equipment selection, interview contractors, request quote and select vendors, supervised base station deployment (structural and telecoms), coordinate facilities, lead technical team in antenna rigging, telecoms switch installation and programming. Performed project commissioning and hand over of deliverables to operations and management.

Delivered telecoms and power infrastructure capital projects of over $1M in scope; within schedule, budget and scope. Saved over 1500 man- hour in project cost. Managed project Safety and Environment team.

Project/Quality Engineer, Austrian Scientific & Technological Contracting, Ltd, Nigeria Dec 1998 - Feb 2001

Member design and planning team, implementation leader for construction and design projects with over $200K in scope, reviewed preliminary designs and blue prints for infrastructure and equipment design, quality, strength of materials and selection of construction materials, selected contractors for corrosion and integrity tests and made recommendation for approval; coordinate all chemical related aspects of projects and safety.

Process Technologist, Mario-Jose Enterprises Ltd., (Tannery Division), Kano Nigeria. Jan 1998 - Nov 1998

Investigate and completed plant upgrade project to reduce environmental pollution due to tannery effluents/waste and waste water discharged by process from plant. Project scope; $90K.

Performed chemical testing and analysis, coordinate raw materials testing and preparation, chemical dispensing and distribution for tanning process.

Managed waste materials/sludge handling and waste water treatment. Coordinate process safety.

Completed environmental impact assessment and process improvement for regulatory compliance.

EDUCATION/TRAINING

Bachelor of Engineering B. Eng (Chemical Engineering) 1997

PROFESSIONAL TRAINING, CERTIFICATION and AFFILIATIIONS

Professional Engineers of Ontario (P. Eng) License. 2013

W.H.M.I.S, Work Place Hazardous Material Information System, Training completed. 2010

Standard First Aid and CPR Level B, Saint John’s Ambulance, -Training completed. 2010

Project Management Professional (PMP), Certified. 2009

Project Management Professional Training, Villanova University, completed, 2009

Pharmaceutical Packaging and Labelling, P S G Canada, -Training completed. 2009

Pharmaceutical Science Group (PSG) Canada, Member since. 2009

Project Management Institute (PMI) Lake-shore chapter, Member since. 2008

Health, Safety and Environment Management Certification, - Completed 2005

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