Symon W. Olenczuk

***** ********** **.

Portage, Michigan 49002

574-***-****

OBJECTIVE: A Sr. Engineering Project Management position in the FDA regulated Industry focusing on capital projects.

SUMMARY:

● BS Industrial Engineering + MBA (85 % complete).

● With 30+ years of engineering in manufacturing plants.

● 25+ years of experience with OTC, RX, consumer/animal health, nutritionals products of various forms like Solids, liquids, ointments, powders, etc.

● 15+ years of Project Management experience for new capital and production improvement projects handled singularly solo up to $8+ Million. Project Mix of Process/packaging - 70% and Utilities/Facilities – 30%.

● 5+ years of Construction Management experience.

● Handled complete project cycle including, technical specification creation, vendor selection, supervision of contractors, validation support, startup/commissioning and final operation handover

● Experience in Project management role supporting multiple plants handling 8-10 projects concurrently

● Full technical understanding of equipment and systems like blending, mixing, formulations, tablet presses, sterile liquid filling, bottling, capping, labeling, packaging, boxing, etc.

● Managed a basic design team for a polysilicon green field build.

● Experienced in closing of a regulated manufacturing facility.

● Expertise with utilities such as compressed air, HVAC, clean water systems, electrical, chillers etc.

● Experience with compliance to various plant regulations like FDA, EU, TGA, OSHA, DEA, EPA, and others.

● Experience with automation systems for production, facility, utility applications. Launched many systems from the ground up, using PLC, Robots, HMI for facility and production systems.

● Appreciation for and able to work well with people from various cultures, languages and skill sets.

● Excellent team player. Work well with engineering, vendors, engineering firms, consultants and plant personnel.

● Local MI person and flexible to travel up to 50%. PROFESSIONAL EXPERIENCE

Voyant Beauty, Elkhart, IN 1/2021 to Present

Senior Project Engineer

● Managing CapEx projects relative to the aerosol industry for the modification of production processes to meet/exceed client and regulatory expectations.

● Identifying and installation of automation production processes such as automated robotic unloading systems, air compressor upgrade/replacement and central bottle depalletizing.

● Facility design, layout and equipment for new and existing production lines.

● Remodel and upgrade Quality Assurance’s Microbiology Laboratory.

● Developed and implemented a Department of Labor approved Apprenticeship programs for Line Maintenance Mechanics and Facility/Building Maintenance trades. Pro Services, Portage, MI 4/2020 to 12/2020

Senior Project Manager

● Responsible for managing a team for the installation of mechanical to Western Michigan University’s new Student Center, Bookstore and Cafeterias.

● Responsible for increasing client/customer base. Stryker Instruments, Portage, MI 11/2019 to 3/2020 Contract Senior Project Manager

● Managing a team to bring on line a dual or secondary qualified source for a high volume commodity as part of their Direct Supplier Optimization (DSO) program.

● Provide input and support to divestiture opportunities. Jacobs Engineering, Indianapolis, IN 2/2019 to 11/2019 Contract Senior Project Manager

● Managing multiple capital projects and teams for Pfizer Inc. in McPherson, KS. Capital projects related to the injectable pharmaceutical industry to meet or exceed FDA, EU and TGA regulatory requirements.

● Projects are to improve cGMP compliance and cross-contamination in their general locker areas, three aseptic gowning rooms.

● Production support with the shelf replacement of a lyophilizer CSM Group, Kalamazoo, MI 06/2014 to 01/2019

Project Manager

● Managing multiple capital projects and teams for Post-Consumer Brands, Battle Creek, MI and Boehringer- Ingelheim Vetmedica in Fort Dodge, Iowa for capital projects related to the pharmaceutical and animal healthcare industries to meet or exceed FDA and EU regulatory requirements.

● Projects are to improve cGMP compliance and improve food safety through better defined hygienic zoning and facility and process upgrades.

● Developed and implemented a program to replace non-hygienic process pumps (90) with hygienic process pumps.

● Initiated an Air Balance Program for four manufacturing buildings with multiple SKU's. Engineering Service Group, Parsippany, NJ 08/2011 to 06/2014 Senior Project Manager

● Managing multi-million-dollar capital projects and teams for Boehringer-Ingelheim Vetmedica in Fort Dodge, Iowa for capital projects related to the pharmaceutical and animal healthcare industries to meet or exceed FDA and EU regulatory requirements.

● Recent projects include: Chiller Distribution System, fire protection and water distribution, document control storage systems, bio-safety level 2 clean rooms.

Dynamic Engineering Inc., Houston, TX 02/2008 to 01/2011 Director Project Management

● Managed three project managers with regard to the Photovoltaic Industry and related Proprietary Intellectual Properties regarding silicon production. Additional responsibility included the General Manager functions of the Houston Office.

● Managed engineers of our Basic Engineering Design team for a Greenfield installation of the company's Proprietary Intellectual Properties regarding polysilicon process, interfacing with EPC, Detailed Design Team and client. Project was in Pocatello, Idaho.

● VP/ GM - Responsible for a 7% to 10% increased projected sales for the Michigan office within the domestic and international markets within the pharmaceutical, food and clean chemical industries. Clark, Richardson, Bisk up (CRB) Consulting Engineers, Kalamazoo, MI 08/2006 to 02/2008 Senior Project Manager

● Managed teams and capital projects for Pfizer Pharmaceutical. This includes equipment specification, selection and installation for an injectable therapy for swines.

● With involvement in fill room design and layout. Other support included: cost analysis, feasibility studies, operations relocation, maintenance support and validation services. Independent Consulting, Elkhart, IN 04/2003 to 02/2006 Self- Employed Consultant

● Provide Project Management/Engineering consulting services for clients regarding relocation of their manufacturing, warehousing, administrative or food service operations. This includes: cost analysis, site preparation, feasibility studies, contract development, and maintenance support.

● Provided a medical device client with cGMP support in a new device for use in operating theaters. Support included a review for compliance with FDA and EU guidelines. Bayer Corporation, Elkhart, IN 09/1981 to 04/2003

Senior Project Engineer/Manager

● Major Projects: Renovation and expansion of R&D Pilot Plant with equipment upgrades ($960,000.00). Remodel and expansion of QA Laboratories with improved air handling and redesigned work stations ($8.5 MM).

● Responsible for developing improved manufacturing layouts that reduced line staffing, improved and increased productivity and reduced scrap levels.

● Capital projects spending maintained an average of 94% to 98% of budget. Expenditures justified through documented sources such as machine downtime logs, work order systems, production reports, and other resources. Realistic timelines for implementation of policies, procedures, purchasing, equipment installation and start-ups, employee training, decommissioning and liquidation of assets.

● Knowledgeable in developing a five-year capital budget for manufacturing and developing maintenance's annual operating budget.

● Provided written justification and submitted these budgets for review at both divisional and corporate levels. Once approved responsible for implementing the budget.

● Acquired, upgraded facilities, installation/start-up and validation of capital equipment for manufacturing. Project range: $2,500 to $8.2 million. Ensured that these acquisitions comply or exceed the current Good Manufacturing Process (cGMP) and industries regulatory requirements.

● Member of implementation team for installation of, Blue Mountain Maintenance Management Software, LIMS data management systems and SAP Data Management System. Responsible for the installation of hardware and the infra-structure to support these data management systems. Involved with the commissioning and start- up of system hardware.

● Working knowledge of cGMPs, cGLPs, FDA, EU, EPA and OSHA to ensure that regulatory guidelines were met or exceeded for; personnel through training, new equipment installation, facility expansion or remodeling, and equipment modifications or relocation.

● Supported R&D and Quality with a new OTC product launch as well as provided manufacturing process information for product NDA submission.

● Responsible for developing and implementing training programs for operators and maintenance personnel when operational changes, new equipment, equipment modification, or procedural changes occur.

● Provide productivity, efficiency, scrap, line balance, staffing and ergonomic analysis of work areas utilizing Classical Industrial Engineering Practices.

EDUCATION:

Regent University, Virginia Beach, VA

Executive MBA (85% complete – currently pursuing)

Engineering/Technology Southern Illinois University, Carbondale, IL Bachelor of Science in Industrial Engineering

CERTIFICATIONS:

Safety Trained Supervisor Construction (STSC)

The STSC is intended for construction supervisors, managers, superintendents, forepersons, crew chiefs, and craftspeople who have responsibilities to maintain safe conditions and practices on construction job sites. These individuals may not have safety as a primary duty, but their knowledge of safety standards and practices ensure safer work sites. OSHA 30-hour Safety Training Completed.

OSHA 10-hour Safety Training Completed.

First Aid and AED Certified.

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