Technical Operations Specialist III; Onsite

Company Description

Abb Vie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about Abb Vie, please visit us at  Follow @abbvie on X, Facebook, Instagram, You Tube, Linked In and Tik Tok.

Support the Technical Operations department through conducting the evaluation, selection, application and adaptation of engineering techniques, procedures, and criteria in manufacturing processes. The position will also be responsible for optimizing manufacturing processes for new and existing products, including ingredient addition, blending, sterilization and transfer methods. This position will support manufacturing by resolving process and equipment issues and preparing drawings, specifications, calculations, charts and graphs.

The position will also monitor work compliance to applicable codes, cGMP, and current safety standards, accepted engineering practices and end user / or standards.

• Based upon knowledge and experience with manufacturing processes, provide on-going support to production operations as well as maintenance to improve the reliability and efficiency of all Compounding operations.
• Preparation and/or modification of the following documents;
  Conceptual designs and process development reports. Block Flow Diagrams (BFD) and Process Flow Diagrams (PFD), Process and Instrumentation Diagrams (P&), Process engineering calculations, Basis of design process scope documents, Equipment layouts, Process equipment and systems specifications, data sheets, and bid tabulations, User Requirement Specifications (URS), and Project status report.
• Apply Engineering and process knowledge to provide technical support to Operations and the mechanics who maintain equipment in the production areas.
• Support the introduction of new products and processes as well as the continuous improvement efforts for existing products
• Interface with other engineering and operational disciplines (mechanical, civil/structural, electrical, instrumentation, automation, architecture, etc.) to ensure a coordinated design and complete deliverables on projects.
• Interface with internal customers and vendors to define project scope, resolve technical issues and assist with preparation of required procurement documents.
• Size and select equipment, materials, and process systems.
• Check vendor drawings to ensure design accuracy and compliance with specifications.
• Incumbent has full authority to make decisions and/or take action that is required to carry out job duties. Internal requirements include compliance with ethics, environmental health and safety, financial, human resources, cGMP procedures, general business policies, requirements and objectives. The incumbent must be willing to take temporary assignments as required.

Regulated Responsibilities (including cGMP and EHS)

Incumbent is expected to be fully compliant with all criteria established by governmental agencies, Ministry of Health, and legislative requirements including, but not limited to: the FDA, European Community (EC), ISO 13485 - Medical Devices, European Economic Community Medical Device Directive (MDD), Canadian Medical Device Regulations (CMDR), OSHA, Sarbanes-Oxley, EPA, DOT, EEOC, and ADA.

Incumbent will work to ensure that the company is in compliance with all environmental, health and safety requirements and assure our business practices enhance the welfare of our customers, employees and the community in which we operate.

• BS in Engineering, Chemical, Electrical, Mechanical or related field of study require
• Experience:
  
  Process Engineering:
  Five (5) years of experience including process engineering experience (addition/mixing/transfer) with solutions, suspensions, or ointments.
• Experience:
  
  Regulatory:
  Two (2) years of experience in the pharmaceutical industry preferred.
• Thorough knowledge of pharmaceutical manufacturing…