Technical Operations Specialist III (Onsite)

AbbVie•Waco, TX

2h•Onsite

About The Position

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&ID), 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.

Requirements

BS in Engineering, Chemical, Electrical, Mechanical or related field of study require
Process Engineering: Five (5) years of experience including process engineering experience (addition/mixing/transfer) with solutions, suspensions, or ointments.
Regulatory: Two (2) years of experience in the pharmaceutical industry preferred.
Thorough knowledge of pharmaceutical manufacturing processes such as mixing, sterilization, clean-in-place, steam-in-place, sanitary piping, tank design, and process automation.
Knowledge of critical / non-critical utility design, installation, and engineering techniques in support of technologies such as sterile solutions, suspensions, emulsions, ointments, creams and gels.
Quality System knowledge (FDA/cGMP, ISO 13485/13488)
Ability to thrive in a team environment.
Understanding of problem-solving methods
Ability to perform risk analysis.
Excellent computer skills in Microsoft Suite.
Ability to read, comprehend, write, and communicate effectively in English.
Ability to carry out detailed written or oral instructions
Detail-oriented and self-motivated
Physically able to continuously stand and walk.
Physically able to lift up to 40 lbs.
Perform other duties as assigned.

Nice To Haves

Working knowledge of AutoCAD a plus.

Responsibilities

Support the Technical Operations department through conducting the evaluation, selection, application and adaptation of engineering techniques, procedures, and criteria in manufacturing processes.
Optimize manufacturing processes for new and existing products, including ingredient addition, blending, sterilization and transfer methods.
Support manufacturing by resolving process and equipment issues and preparing drawings, specifications, calculations, charts and graphs.
Monitor work compliance to applicable codes, cGMP, and current safety standards, accepted engineering practices and end user / or standards.
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 documents such as Conceptual designs and process development reports, Block Flow Diagrams (BFD) and Process Flow Diagrams (PFD), Process and Instrumentation Diagrams (P&ID), 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.
Make decisions and/or take action that is required to carry out job duties.
Compliance with ethics, environmental health and safety, financial, human resources, cGMP procedures, general business policies, requirements and objectives.
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.
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.