Description

Job Summary:

The Technical Services Associate-I will assist with and/or execute process and product improvement studies supporting commercial product lifecycle management activities for pharmaceutical products. Working collaboratively with multiple teams, the position will have the chance to make a significant impact by improving existing products, addressing manufacturing issues, evaluating new technologies and ingredients, seeking cost savings, and assisting with the development and transfer of products and processes.

Qualifications

Job Responsibilities

• Carries out responsibilities in accordance with Aveva’s policies, procedures, and safety rules in accordance with local, state and federal laws.
• Provides support, coordinates, and executes experimental studies supporting improvements or modifications to commercial products and/or processes. 
• Interfaces with R&D, Production, Analytical Development / QC, Quality Assurance, Engineering and Regulatory departments to carry out project objectives.
• Assists with troubleshooting process problems and assists in process optimization.
• Assists with the investigation of process failures and discrepancies to assess impact upon product quality and validation status.
• Evaluates and implements cost-saving initiatives, including implementation of alternative raw materials,  supplies, and procedures.
• Prepares specifications for alternative raw materials and components.
• Supports improvements in manufacturing and control systems including corrective and preventative actions (CAPA).
• Supports technology transfer initiatives within the company or with external facilities.
• Assists with or leads drafting of protocols to establish product and process specifications and procedures.
• Prepares final reports and assures they are approved through proper channels.
• Assists the R&D department with the development and scale-up of manufacturing processes.
• Assists with or leads the preparation of manufacturing batch records (MBRs) and supporting documents.
• Provides supervision of manfactruing activities supporting R&D/Tech Services projects, such as supervising beldning, coating, and packaging operations.
• Performs related duties as assigned.