Skip to main content

Search jobs

Search jobs

About AbbVie

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 Mfg Associate I – Operations New Production Introduction Engineer

Worcester, Massachusetts Req ID 2212376 Category Manufacturing & Operations Division AbbVie

With minimal supervision responsible for the management of New Product Introductions (NPI) as Operations New Production Introduction Engineer. Responsibilities including the introduction of new projects and technology into Production, manufacturing improvement initiatives, suite, and equipment readiness and process validation support. Works in concert with peers or senior staff in other departments to meet project timelines. Responsible for tracking the transfer, implementation, and monitoring of projects. Able to identify opportunities for improvement of manufacturing and business processes.

Responsibilities: 

  • Works with cross functional team to facilitate NPI process fit; including batch record review, assistance with area engineer to ensure process fit within BU3 manufacturing suites, work with Tech transfer to produce standardized and efficient clinical batch record. Supports established project campaigns as needed.
  • Support business area process validation activities when needed to ensure area documentation aligns with quality documentation for process validation.
  • Schedules work tasks, without assistance, to support project and campaign timelines.
  • Reviews documents with diverse scope and complexity. Manages document review and approval for the operations group to meet project timelines.
  • Exercises judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results.
  • Tracks ongoing problems and gathers information for analysis. Uses analysis to develop solutions to broad-level problems. Presents potential solutions to management and senior personnel, and with limited assistance creates an implementation plan. Develop BU3 metrics and help establish meaningful KPIs to identify and enable continuous improvement in tech transfer and new product introduction.
  • Applies knowledge, experience, and technical skills to understand production objectives and evaluate potential changes, implement production initiatives. Executes systems and procedures efficiently and compliantly and evaluates systems for improvement potential. Develops and uses standard practices to ensure inter-group consistency.
  • Coordinates activities of subgroup and actively works under other sub-groups. Provides technical direction and training to less senior personnel.
  • Frequently interacts with subordinates and functional peer groups. Interaction normally requires the ability to gain cooperation of others, conducting presentations of technical information concerning specific projects, schedules, etc.

 


Qualification: 

•Bachelor’s Degree or equivalent required.

•At least 5 -8 years’ experience in all aspects of manufacturing and production processes.

•Knowledge of media and buffer preparation, cell culture and purification of biological drugs is required; Computer expertise and scheduling proficiency; In-depth knowledge of safety, quality systems, and current Good Manufacturing Practice is required; Expertise with tech transfer process and familiarity with equipment, facilities validation, and regulatory filings.

•Must be flexible to handle multiple tasks including ability to handle pressure in a professional and positive manner; Effectively works in a team environment; Maintains high level of energy and professionalism on the job; Builds effective working relationships with customers, co-workers, cross-functioned groups, and management.

•Uses problem solving skills when working on complex problems, where analysis of situations requires an in-depth evaluation of various factors.

•Uses discretion and works under general supervision; Follows established procedures. Decisions are reviewed for soundness of technical judgment. Independently decides when to make minor adaptations or modifications.

•Coordinates the completion of daily operational activities across a unit or sub-unit. Decisions, recommendations and actions contribute to the development of suite schedules and personnel allocation.

•Provides technical direction and training to less senior personnel; Coordinates activities of sub-group and actively works with other sub-groups. Acts as advisor to unit or sub-unit becomes actively involved as required. Provides technical direction and training to less senior personnel. Participates in technical investigations and provides on the floor technical expertise; Provides a motivational and team building atmosphere. Acts as a mentor.

•Frequently interacts with subordinates or functional peer groups at various management levels. Interaction normally requires the ability to gain cooperation of others, conducting presentations of technical information concerning specific projects, schedules, etc. Regularly discusses progress, problems, and proposed solutions with colleagues and senior personnel.

•Detailed understanding of current Good Manufacturing Practices as applied to equipment and process steps in area of responsibility. Able to make recommendations for improved compliance at plant level. In-depth knowledge of pertinent regulatory filings.

Significant Work Activities: Continuous walking for prolonged periods (more than 2 hours at a time in an 8 hour day)
Travel: No
Job Type: Experienced
Schedule: Full-time
ABBVIE

Most recent jobs

Sign up for job alerts

Join our talent network and receive AbbVie news and job alerts to your inbox.

Interested InPlease select a category or location option. Click “Add” to create your job alert.

  • Manufacturing & Operations, Worcester, Massachusetts, United StatesRemove

Our Terms of Use, Cookie Policy and Privacy Policy explain how we collect and use information about you and the rights you have. By submitting your information, you acknowledge you have read those documents and consent to receive SMS communications and email jobs alerts from AbbVie.

Recently viewed jobs

You have not viewed any jobs recently.

Phishing scam alert

As an online job seeker, you could be a target of cyber (online) thieves seeking to secure personal information from you by sending you “phishing” messages.

Please be alert to and protect yourself from phishing scams. Find out how you can avoid being a victim of job phishing scams.

For Internal Candidates only - Notice of Filing of Labor Condition Application

Equal Employment Opportunity | Reasonable Accommodation