Profile
Skills
Accomplishments
Professional Experience
Mark Pittman
5257 East Pleasant Run Parkway South Drive
Indianapolis, IN 46219
H: 317-357-9091
M: 317-601-7319
mdpittman@att.net
Results driven engineer who can qualify and validate facilities, utilities and equipment, and
can manage projects successfully.
Can develop and scale-up pharmaceutical oral products and processes from the laboratory to
production, including both batch and continuous dry product manufacturing processes.
Project management
Facility, utility and equipment design,
qualification and validation
GMP Compliance
FUME Quality Systems
C4i
Data analysis
Pharmaceutical process development
and scale-up
Tablet compression
Tablet coating
Product milling
Technical report writing
Led the design, installation and qualification of a highly potent active pharmaceutical
ingredient milling suite
Led the qualification of a biosynthetic insulin manufacturing facility
Created a commissioning and qualification standard and procedure for all corporate product
development sites
Removed a hazardous chlorine gas injection system from a high purity water system, earning
a global company safety award
Led the successful technical transfer of a pharmaceutical tablet process to a production site
June 1991
to
November 2015
Indianapolis, INEli Lilly and Company
Associate Consultant Engineer
Led the capital approval, design, construction, and qualification of a high containment level
dry milling GMP production suite including milling equipment and glovebox.
Created a commissioning and qualification standard and procedure for all Eli Lilly GMP
product development sites.
Operated, maintained and improved high purity water systems, using C4i principles and
including capital project implementation, qualification and validation of additional purified
Education and Training
water loops and ports.
Removed a hazardous chlorine gas injection system from a high purity water system, earning
a global company safety award.
Led the qualification of a GMP insulin manufacturing facility. Designed and oversaw
procurement and construction of biodevelopment facility tanks, agitators, and support
equipment.
Developed pharmaceutical tablet formulation processes and successfully transferred to
production sites for clinical manufacturing.
Determined parameters for blending, tablet compression, and tablet coating unit operations
and operated equipment to produce tablets for both batch and continuous drug product
manufacturing processes.
Developed active pharmaceutical ingredient (API) batch processes to scale-up from
laboratory to GMP production equipment. Identified a API polymorph and developed a
conversion process from filtered crystals to the desired polymorph.
Led the development and GMP production campaigns of dry and slurry milled API lots.
Determined choice of dry milling particle size technology and suitable milling parameters for
scale-up.
Indianapolis, IN, USAPurdue University
Bachelor of Science: Chemical Engineering

Mark Pittman Qualification and Validation Resume

  • 1.
    Profile Skills Accomplishments Professional Experience Mark Pittman 5257East Pleasant Run Parkway South Drive Indianapolis, IN 46219 H: 317-357-9091 M: 317-601-7319 mdpittman@att.net Results driven engineer who can qualify and validate facilities, utilities and equipment, and can manage projects successfully. Can develop and scale-up pharmaceutical oral products and processes from the laboratory to production, including both batch and continuous dry product manufacturing processes. Project management Facility, utility and equipment design, qualification and validation GMP Compliance FUME Quality Systems C4i Data analysis Pharmaceutical process development and scale-up Tablet compression Tablet coating Product milling Technical report writing Led the design, installation and qualification of a highly potent active pharmaceutical ingredient milling suite Led the qualification of a biosynthetic insulin manufacturing facility Created a commissioning and qualification standard and procedure for all corporate product development sites Removed a hazardous chlorine gas injection system from a high purity water system, earning a global company safety award Led the successful technical transfer of a pharmaceutical tablet process to a production site June 1991 to November 2015 Indianapolis, INEli Lilly and Company Associate Consultant Engineer Led the capital approval, design, construction, and qualification of a high containment level dry milling GMP production suite including milling equipment and glovebox. Created a commissioning and qualification standard and procedure for all Eli Lilly GMP product development sites. Operated, maintained and improved high purity water systems, using C4i principles and including capital project implementation, qualification and validation of additional purified
  • 2.
    Education and Training waterloops and ports. Removed a hazardous chlorine gas injection system from a high purity water system, earning a global company safety award. Led the qualification of a GMP insulin manufacturing facility. Designed and oversaw procurement and construction of biodevelopment facility tanks, agitators, and support equipment. Developed pharmaceutical tablet formulation processes and successfully transferred to production sites for clinical manufacturing. Determined parameters for blending, tablet compression, and tablet coating unit operations and operated equipment to produce tablets for both batch and continuous drug product manufacturing processes. Developed active pharmaceutical ingredient (API) batch processes to scale-up from laboratory to GMP production equipment. Identified a API polymorph and developed a conversion process from filtered crystals to the desired polymorph. Led the development and GMP production campaigns of dry and slurry milled API lots. Determined choice of dry milling particle size technology and suitable milling parameters for scale-up. Indianapolis, IN, USAPurdue University Bachelor of Science: Chemical Engineering