Technical Operations Specialist III (Onsite)

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.

Qualifications :

• 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 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.
• Working knowledge of AutoCAD a plus.
• 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.

Additional Information :

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: 

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time ofthis posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic locationand we may ultimately pay more or less than the posted range. This range may be modified in the future. 
• We offer a comprehensive package of benefits including paid time off (vacation holidays sick) medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our short-term incentive programs. 

Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of anybonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys soleand absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable law. 

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. 

US & Puerto Rico only - to learn more visit  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

No

Employment Type :

Full-time