Martin Radecki Email & Phone Number

Des Plaines, Il, Us

Rosemont, Il, Us

Project Manager for a global biopharmaceutical, diagnostic and medical device companies.Responsibilities: • Provide internal leadership within both the project team and the company as a whole toward the successful completion of assigned programs • Lead a cross-functional teams while providing expertise in functional specialty (i.e. tooling, automation, process engineering, product design, quality, validation, or manufacturing engineering). Interface directly with outside tooling vendors as well as representatives from multiple manufacturing destination sites, throughout Europe• Communicate with internal and external resources to ensure responsibilities and milestones are clear and achievable, and maintain project plans for internal and external use • Generate quotes and estimates for equipment, instruments, tooling, molding and associated installation and C&Q services • Identify and collaborate with outside suppliers and service providers as needed • Participate in ongoing, company-wide improvement efforts • Responsible for development of design control documentation, development of material supply studies, review of product design verification and validation, and alignment of design transfer methodologies across company’s manufacturing sites in Europe and US• Responsible for development of engineering, validation and design transfer strategies for both international and US sites, ranging from engineering design, vendor fabrication/acceptance testing/procurement and validation• Manage diverse groups and multinational personnel of different level engineers, contractors and technicians during all stages of design, FAT, SAT, commissioning, validation, and stability/manufacturing runs• MES/LIMS/Quality Management System Implementation

Abbott Park, Illinois, Us

Leading implementations of quality systems at newly acquired start-up and managing projects in existing in-vitro diagnostic manufacturing facility. Including:- Managing up to 10 contractors- Process Improvements- Budgeting / Scheduling- Characterization Studies- Engineering Studies- IQ/OQ/PQ

Lake Forest, Il, Us

Served on point to design, develop, install / qualify new and improve existing equipment and processes. Collaborated across functions & levels to lead, coordinate and execute projects. Utilized experience in aseptic processing, lyophilization, sterilization, best practices & methodologies, standards and design & qualification requirements, in accordance to the FDA and other regulatory agencies.

Conducted a range of commissioning and qualification activities across all equipment, facilities, HVAC systems, utilities and automated process controllers. Partnered with various functional groups to enhance existing systems and implement innovative technologies.

Melbourne, Victoria, Au

Conducted a range of qualification activities across processes, equipment, facilities, HVAC systems, utilities and controls for plasma protein biopharmaceutical industry leader. Partnered with various functional groups to enhance existing systems and implement innovative technologies. Provided quality oversight as part of the change control management process for new product introductions and engineering projects.

Ms, Chemical Engineering

Bs, Chemical Engineering