MICHAEL GRAIKA
Cell: 508-***-****
Email: ****.******@*****.***
An experienced Professional with extensive process improvement and quality knowledge gained over 30 years
working experience in a FDA regulated pharmaceutical industry.
WORK HISTORY
Sept. 2012 to Present
Part time Process Engineer
IPS, Integrated Project services
PA.
Outside service provider assigned to Astra Zeneca tasked to increase overall equipment efficiencies of blow, fill and
seal equipment.
• Utilized 5S, Lean, value stream mapping and TPM events to improve efficiencies.
• Developed changes to maintenance procedures to increase uptime.
• Set standards for finished product.
• Assist mechanical staff in troubleshooting production equipment problems.
• Developed process changes to reduce scrap.
Jul 2001 to Jun 2011
Maintenance Supervisor
AstraZeneca Pharmaceutical
Westborough, Mass
Responsible for leading the maintenance, reliability and continuous improvement initiatives for the blow, fill and seal
dept over 3 shifts of production. Served as Production Supervisor during vacancies and vacations.
Directed 20 plus mechanics responsible for maintaining various manufacturing equipment including
•
Rommelag blow, fill and seal equipment
Maintained budgets for spare parts and major overhauls of equipment
•
Responsible for adherences to efficiency and quality goals for department equipment
•
Wrote yearly objectives for staff, appraised performance and administered discipline as required. Responsible
•
for hiring staff and assigning appropriate training
Developed changes to Standard Operating Procedures and Preventive Maintenance steps.
•
Lead investigations of Quality Deviations associated with equipment problems and developed corrective /
•
preventative actions associated with deviations
Lead troubleshooting exercises using 5Y, Fishbone and other methods
•
Utilized 5S and other methods to ensure work areas were organized
•
Assisted in FDA audits
•
Conducted investigations of customer complaints for manufacturing defects and developed corrective and
•
preventive actions
Interfaced with OEM’s and suppliers
•
May 1996 to July 2001
Engineering Mechanical Technician
AstraZeneca Pharmaceutical
Westborough, MA
Provided engineering services to production departments including advanced troubleshooting of equipment problems.
• Lead engineering activities for new product launches
• Wrote equipment specifications for capital improvement projects
• Lead factory acceptance testing of equipment
• Wrote engineering test plans in support of equipments changes
• Responsible for budget tracking of assigned capital projects
• Assisted Mechanics in complicated equipment repairs
Education
Bay View High School Milwaukee, Wisc. Over 15 years experience in various industries as a Maintenance Mechanic.
Lean Manufacturing Certified.
SOFTWARE/SYSTEM SKILLS
Microsoft Office, SAP and basic AutoCad
REFERENCES
References provided upon request