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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.

Manufacturing Process Engineer

Branchburg Township, New Jersey Req ID 2206011 Category Manufacturing & Operations Division AbbVie

The Manufacturing/Process Engineer III will lead, and when applicable support, tasks required to transfer/implement new technologies into the manufacturing environment. The engineer will lead product line extension initiatives to ensure a successful expansion of the product portfolio, technology, and/or manufacturing capacity. The engineer will also recommend continuous improvement and new technology programs based on experience obtained from time on the production floor and designing production scale equipment.

 

Responsibilities include 1) providing engineering support, and when applicable lead, in the creation 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 support, and when applicable lead, investigations of issues pertaining to products, processes, and technologies by applying effective root cause analysis tools, 3)  creating strategies and designs for more complex validations, drafting and executing protocols, data analysis and report creation.

 

 

 

KEY DUTIES AND RESPONSIBILITIES: Describe scope:

% of Time or

Importance

Leads and participates on project teams or internal teams for new product/technology 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 strategy. Influences Senior Management and defends strategy, risk, timing, etc. and obtains approval on key decisions

45%

Contributes to the completion of milestones associated with specific projects. Works independently and leads internal teams. Identifies & recommends inputs for projects of medium complexity while soliciting feedback/confirmation from senior staff on more complex projects. Application of organizational understanding and systems to adequately plan deliverables, milestones and durations. Prepares and proposes initial resource requirements to senior staff for review and concurrence. Identify vendors, obtain quotes, prepares purchase requisitions. Demonstrates agility to react to obstacles and recommend alternative plans.

45%

Serves as an extended core team member (leading when applicable), assisting in document writing (SOPs, Validation Protocols, Qualifications Protocols, Batch Records, etc.), executing validation/qualification protocols, coordinating first builds, training manufacturing staff, managing change controls, etc. Prepares and delivers materials for meetings, focus groups and Director level presentations in order to effectively communicate activities.

5%

Applies statistical techniques and report’s findings to supervisor with recommendations in order to 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%


Education and Experience

  • A minimum of a Bachelor’s degree in a technical field with 3-5 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. Ability to analyze issues, and develop and deploy solutions within a dynamic environment.
  • 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.
  • Understanding and use of statistical methods in experiment design, data analysis, development of robust manufacturing processes, and/or validation.
  • 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.
  • Established 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.
  • 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: Yes, 10 % of the Time
Job Type: Experienced
Schedule: Full-time
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