Senior Process Engineer (Biologics Manufacturing) - Pipeline

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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

The Senior Engineer is entrusted with the vital role of delivering engineering support for Biologics manufacturing.  This engineering professional will work independently with little or no supervision; utilizing scientific knowledge, engineering expertise, mathematical aptitude, lead equipment and process troubleshooting, manage medium to large projects, and problem-solve to successfully complete assignments in a specific technical field or discipline.

Responsibilities

• Perform process monitoring of cell culture and purification operations, as well as Steam in Place (SIP) and Cleaning in Place (CIP) operations. Lead troubleshooting activities and mentor less senior engineering staff to resolve process/equipment anomalies. Describe and communicate required actions to internal and external stakeholders with varying levels of technical acumen. Engage with operational staff on the floor in a GMP cleaning room setting to understand what activities are being performed. Leverage extensive process and engineering knowledge to identify issues on the production floor proactively and innovate solutions.


• Plan and conduct medium to large sized assigned projects related to bioprocessing equipment and process improvements. Project may require identification of scope and determining overall action plan and timeline. Additionally, it requires generation of validated change plans with validation requirements. Able to execute actions of those plans with minimal oversite and independently resolve issues as they arise. Communicate progress to all stakeholders through verbal and written communications.


• Leverage engineering and process background to execute facility fit activities independently in support of New Product Introduction (NPI) from clinical phase 1 to commercial projects. NPI activities also include equipment walkdowns, batch record review, leading technical discussions and working with vendors. It is expected that Senior Engineers are an integral part of the NPI process often bridging the gap between Develop and Operational groups.


• Support capital project execution in the areas of design, validation, FAT, SAT, and specification review, for production equipment.


• Build relationships, initiate, and cultivate open, honest relationships with colleagues, customers, contractors, and vendors by establishing rapport, developing an understanding of others’ needs, promoting common goals, and following through on commitments.


• Convey information effectively through verbal, written, and presentations to stakeholders and team members, both internal and external to AbbVie, using appropriate communication protocols. Identify ways to increase customer satisfaction. Document agreements and commitments and keep direct customers informed.


• Facilitate the definition of a project scope with stakeholders. Convert goals to tasks and steps. Within structure, plan own work, manage several, often concurrent, tasks to accomplish assigned tasks to meet or exceed expectations (cost, quality, time). Participate in basic economic analysis and feasibility studies related to project alternatives under guidance. Jointly responsible for achieving the project’s financial targets in support of business objectives.


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• Bachelor’s Degree in Engineering, Science, or related discipline, with minimum 5+ years of significant engineering and/or operational experience. Post-graduate education/degree is desired and may contribute towards the desired years of experience.


• Demonstrated competency within a specific discipline.


• Strong technical knowledge and application of concepts, practices, and procedures.


• Ability to work on complex problems with multiple competing factors, demonstrating judgment within defined procedures and practices to determine appropriate action.


• Excellent interpersonal skills, including the ability to work well with diverse groups within engineering and maintain strong working relationships with internal and external collaborators.


• Active listening and effective communication skills, including the ability to articulate tactfully and respectfully one's own perspective orally, in writing, and in presentations.


• Collaborative mindset, working well with other engineers in a fast-paced, goal-driven environment.


• Interpersonal skills to negotiate and reconcile differences.


• Demonstrated competency with financial systems and fiscal control.


• Technical background in health care, medical devices, pharmaceuticals, biologics, or similar industries preferred.

AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion.  It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.