Mark Macciomei

Work as maintenance team lead on projects such as L15 liquids pkg project, L06 project, L14 project , with acquisition of equipment from Akorn Pharma, including procuring equipment, spare parts

Manuals etc.

Maintenance team lead for acquisition of Insys Phama equipment assets, leading to install, development and production of UD01 packaging line (Klodaxxo product)

Maintenance team lead for install of L02 pkg equipment including filler, bundler and end of line pkg equipment. Played role as “acting engineer” as engineer was away on business in Europe.

Maintenance team lead for install of MDI cartoner and bundler.

Work within time and budget constraints on all projects

See projects through from conception, design review, FAT’s, install SAT, validation, qualification, acquisition of spare parts, instruction manuals, tech training, writing of maintenance work instruction, hosting of equipment vendors.

Provides review of new products / packaging regarding fit with operational capabilities (e.g. ability of components to run on a particular line, etc.), independently for processes of low to medium complexity (e.g. low

• Collaborates with Change Management to support packaging and packaging component changes (e.g. CMU process).
• Shares and learns from best practices across the organization (PCs, Packaging Engineering Forums, etc.); shares observations from data reviews, highlight common errors, identify potential solutions to common errors, etc.
• Meets cGMP, FDA, DEA, OSHA and other applicable regulatory and company guidelines.complexity may be standard packaging components - bottle, cap, desiccant, cotton; medium complexity may be new components, new tooling, international Brand), and in consultation with senior Packaging Engineers and / or functional management for complex processes (e.g. powder filling, nasal sprays, cold chain], or processes with approaches rarely used (such as controlled atmosphere such as low relative humidity, glass vials, patches).
• Ensures attention to detail to documentation to ensure quality and timeliness of documents.
• Ensures attention to detail to documentation to ensure quality and timeliness of documents.