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AbbVie’s mission is to discover and deliver innovative medicines 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, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Senior Engineer, Manufacturing/Process

Branchburg Township, New Jersey Req ID 2207809 Category Engineering Division AbbVie

The Manufacturing/Process Engineer IV will lead all tasks required to transfer new product designs, product line extensions and continuous process improvements into manufacturing (or through contract manufacturing) to ensure successful commercialization’s, corrective actions and cost reductions while delivering robust, repeatable and reproducible processes.

 

Responsibilities include 1) providing Operations Engineering leadership and support in the development and implementation of process requirements and specifications for manufacturing processes in support of design transfer, process validation, product line extensions and continuous improvement activities in a cross-functional environment, 2) providing leadership and support during investigations of issues pertaining to products and processes by applying effective root cause analysis tools, 3) creating strategies and designs of complex validations, 4) contributing to the completion of specific programs and projects.

 

The Manufacturing/Process Engineer IV applies in depth technical knowledge or subject matter expertise to complex situations. The Manufacturing/Process Engineer IV creates new opportunities or eliminates a potential issue by making sound decisions. The Manufacturing/Process Engineer IV carries a complete project load including the review and recommendations of other professionals. The Manufacturing/Process Engineer IV demonstrates consistent application of thorough and robust project planning capability to ensure a proven and successful track record of project completions.

 

 

 

 

KEY DUTIES AND RESPONSIBILITIES: Describe scope:

% of Time or

Importance

Leads and participates on project teams or internal teams (Operations Lead) for new product introductions and product support activities (line extensions) to ensure successful transfers. Presents to all levels of the organization and external third parties. Interfaces with various departments to ensure processes and designs are compatible with the manufacturing environment, Operations strategy, and LifeCell's/AbbVie BBG strategy. Influences Senior Management and defends strategy, risk, timing, etc. and obtains approval on key decisions

50%

Write SOPs, Validation Protocols, Qualifications Protocols, Batch Records, etc., for complex validations, novel equipment and processes. Executes validation/qualification protocols, coordinates first builds, trains manufacturing staff, etc. Reviews and guides lower professional’s work in this area

25%

Contributes to the completion of specific programs and projects where the results have a considerable impact on schedules, programs and resource allocations. Appropriately and consistently identifies stakeholders, scope of work, and resource requirements required to identify and complete concept, feasibility, development, transfer and release phases of a project lifecycle

15%

Proficient with advanced statistical techniques and analysis. Reports and translates findings in layman’s terms to others. Reviews and advises statistical analysis to lower level professionals. Challenge experimental designs, general engineering principles, process excellence principles, problem solving principles, and design for manufacturability as it relates to process changes and/or new product transfers

5%

Current on company business drivers and proactively recommends changes to systems. Proactively investigates and identifies opportunities for improvement

5%


Education and Experience

  • A minimum of a Bachelors degree in a technical field with 5+ years industry experience in Medical Device, Biotech or Pharmaceutical industries. Solid time management skills and follow-through skills with the ability to work on and manage multiple tasks and projects with tight deadlines. Ability to exercise professional discretion and judgement.
  • Experience with new product, equipment, and/or technology development in the medical device or pharmaceutical industry, including proven skills in specification development, design, fabrication, qualification, and troubleshooting.
  • Established use of statistical methods in experimental design, data analysis, development of robust manufacturing processes, and/or validations.
  • Experience with Quality System Regulations (QSR) and Design Control, and understands AATB, ISO, and/or FDA guidelines as related to Human Tissue Processing and Medical Device Manufacture.
  • Demonstrated ability to analyze issues and develop and deploy solutions within a dynamic environment.
  • Established strong verbal, written, and interpersonal communication skills with an ability to interface at all levels of business environments regarding technical content in a clear and easy-to understand way.
  • Demonstrated ability to present to senior management, defend strategy, timing, resource needs, risks, and plan, and obtain approval on key decisions such as release of funds and phase gate advancement.
  • Strong organizational skills and ability to manage time effectively; ability to concurrently handle multiple project assignments.
  • Experience with Microsoft Applications including Word, Excel, PowerPoint, Outlook, Project and Visio
Significant Work Activities: Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel: No
Job Type: Experienced
Schedule: Full-time
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