Global Process Engineer (Aseptic)
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What you'll do
- Serves as organization spokesperson on advanced projects and/or programs related to aseptic operation including equipment selection. Presents results of projects both internally and externally.
- Acts as advisor to management and operating sites on applications of new advanced processing equipment and participates in project planning, process update
- Responsible for timely project completion.
- May act as lead engineer, project leader, or project contributor.
- Ensures quality and effectiveness of aseptic solutions as part of major projects through sound design, early risk assessments, and implementation strategies. Has full awareness of the potential consequences (defects and failure modes) of design changes to established processes.
- Evaluates and integrate relevant engineering advances for improving or solving problems.
- Understands the business implications of assigned products and processes and identify engineering solutions compatible with business needs.
- Provides technical direction and feedback to others.
- Responsible for compliance with applicable corporate and local policies and procedures.
What they're looking for
- MS or PHD in Mechanical, Chemical Engineering or related field with 6 to 8 years of engineering experience in pharmaceutical aseptic process design, equipment selection and operation in general aseptic processing, upstream and downstream biological processing, or aseptic fill finishing
- Good knowledge of Aseptic fill finish technology and suppliers
- Good knowledge of Broader compounding, built infrastructure (cleanroom design, services (water, HVAC…..)
- Good knowledge of Knowledge of regulatory environment and requirements both in Europe and the US
- Good knowledge of Methods of Microbial control and environmental monitoring
- Good knowledge of Control and information systems used in secondary pharma and fill finish on particular
- Good knowledge of Understands both equipment control and SCADA and MES levels.
- Good knowledge of Secondary packaging
- Good knowledge of Single use systems
- Good knowledge of Cleaning and sanitisation methodologies.
- Good knowledge of Knowledge about associated technology (Lyophilisation, Blow Fill Seal)
- Good knowledge of Application of robotics
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
Company Description
About AbbVie
AbbVie'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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Job Description
Purpose
The Global Process Support Engineer (Aseptic) will support the AbbVie Technical Operations Functions and the AbbVie Technical Centers worldwide. This position will be responsible for applying advanced scientific knowledge, engineering knowledge, mathematics, and ingenuity to complete complex assignments related to aseptic capital projects and aseptic process troubleshooting. The selected candidate will contribute to the development of new principles and concepts and is expected to lead change from an engineering perspective. Will also be responsible for solving operating issues and providing technical support to cross-functional teams within the Aseptic sites.
Responsibilities
- Serves as organization spokesperson on advanced projects and/or programs related to aseptic operation including equipment selection. Presents results of projects both internally and externally.
- Acts as advisor to management and operating sites on applications of new advanced processing equipment and participates in project planning, process update
- Responsible for timely project completion.
- May act as lead engineer, project leader, or project contributor.
- Ensures quality and effectiveness of aseptic solutions as part of major projects through sound design, early risk assessments, and implementation strategies. Has full awareness of the potential consequences (defects and failure modes) of design changes to established processes.
- Evaluates and integrate relevant engineering advances for improving or solving problems.
- Understands the business implications of assigned products and processes and identify engineering solutions compatible with business needs.
- Provides technical direction and feedback to others.
- Responsible for compliance with applicable corporate and local policies and procedures.
Qualifications
MS or PHD in Mechanical, Chemical Engineering or related field with 6 to 8 years of engineering experience in pharmaceutical aseptic process design, equipment selection and operation in one of the following areas:
• general aseptic processing;
• upstream and downstream biological processing;
• aseptic fill finishing
Good knowledge of:
• Aseptic fill finish technology and suppliers
• Broader compounding, built infrastructure (cleanroom design, services (water, HVAC…..)
• Knowledge of regulatory environment and requirements both in Europe and the US
• Methods of Microbial control and environmental monitoring
• Control and information systems used in secondary pharma and fill finish on particular
• Understands both equipment control and SCADA and MES levels.
• Secondary packaging
• Single use systems
• Cleaning and sanitisation methodologies.
• Knowledge about associated technology (Lyophilisation, Blow Fill Seal)
• Application of robotics
Understanding of:
• typical process analysis and troubleshooting tools.
• high containment processing
• change control requirements
• key literature beyond regulations (ISPE, AMSE, ISO, USP)
• project costing, lead times, control and management
• broader commercial environment in the Pharma industry.
Experience:
• Demonstrated excellence in breadth and depth of knowledge within the aseptic discipline and is recognized as a subject matter expert
• Experience active participating or leading FMEA, Risk Assessments and/or Investigations for aseptic pharmaceutical processes.
• Must demonstrate negotiation skills and ability to reconcile differences
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 of thisposting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location,and 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 long-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 any bonus, commission,incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless anduntil paid and may be modified at the Company’s 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 https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
Company
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