PRINCIPAL DUTIES
1. Provides engineering technical support and project management related to the transfer of new products/processes from development to the manufacturing operations or between manufacturing facilities. Oversees action items associated with the transfer process to assure efficient and timely completion of projects.
2. Determine the best approach to producing products within the scope of compliance and cost effectiveness. Recommends improvements and refinements to existing products to resolve manufacturing issues.
3. Participates in the development of project scopes, cost estimates and schedules for capital and plant improvement projects to support new products
4. Writes user requirement, functional and design specifications for new equipment, utilities and facilites as required for new product introductions to manufacturing. May conduct or support equipment FAT and commissioning activities.
5. Advises management on the practicality, feasibility and impact of new equipment and retrofit of existing equipment and facilities for new products.
6. Write and maintain the necessary documentation (SOP’s, maintenance requirement, batch records) for effective manufacturing transfer process and sustained process execution in routine production.
7. Contribute to or lead quality investigations into process deviations and provide CAPA support.
8. Supervises technical service specialists.
KNOWLEDGE, SKILLS & EXPERIENCE REQUIRED
1. Bachelor of Science degree in engineering degree required, with specialization in chemistry or pharmacy discipline, preferred. Additional education or professional development in project management is recommended.
2. Minimum 10 years experience in the pharmaceutical industry ideally in product development and/or pharmaceutical manufacturing area minimum of 5 years project supervision experience.
3. Experience working with small volume parenterals, terminal sterilization, lyophilization and maintenance manufacturing processes preferred.
4. Proficiency in the use of Microsoft Office products including project planning techniques and software.
5. Strong written and oral communication skills.