Company Description
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.
Job Description
Purpose
The Process Engineer will apply scientific knowledge, engineering knowledge, mathematics, and ingenuity to complete assignments within ABC’s New Product Introduction and ADC Suites. The engineer will be responsible for providing support to all operations required for the production of monoclonal antibodies and antibody-drug conjugates for the development of new drug products. Operations include cell culture, harvest, purification, antibody and payload conjugation, formulation, and bulk product fill.
Responsibilities
- Responsibilities of this engineering grade level inherently include and expand upon the responsibilities established for lower engineering grade levels.
- Responsible for compliance with applicable policies and procedures.
- Leads equipment and process troubleshooting efforts. Works closely with the maintenance, quality, manufacturing operations, safety, and process development teams to implement equipment and/or process changes, as required.
- Perform Process / Facility fit activities to enable engineering and qualification runs of new products. This includes selection of proper equipment scale and configuration, identification of consumables required such as single use containers, tube sets, etc., verification that required critical documentation is accurate and in alignment with Technology Transfer package from the development process parameters are attainable by available equipment, and verification that batch record team.
- Plans and conducts small- to medium-size assigned projects within engineering specialty requiring conventional types of plans, investigations, and/or equipment. Coordinates and monitors activities/projects. Reviews plans and monitors status of implementation for those assigned to project; makes judgments regarding quality of implementation within discipline; employs contingency plans to recover from schedule slippage and financial overruns when appropriate. Works with the quality team and other stakeholders to develop and implement Corrective/Preventive (CAPA) actions, as required from the investigations.
- Estimates and coordinates resources needed (materials, budget, time and people) to accomplish assigned individual tasks. Anticipates future directions. Benchmarks internally and externally. Recognizes changes in the environment and present resources as indicators of future problems and opportunities; prepares for such eventualities.
- Independently executes the design of products/processes/equipment/systems/facilities by applying standard engineering theories, concepts, and techniques within the discipline. Independently investigates, conducts tests or experiments.
- Creates/modifies designs for intermediate problems. Designs/modifies more complex components/processes; writes detailed design specifications. Predicts patterns/trends. Grasps complexities and sees relationships among data; determines consequences and alternatives; makes recommendations.
- Improves methods/designs/processes. Recognizes and implements good ideas/innovations/costs reductions; consistently generates/adopts original solutions to problems and reduces them to practices.
- Mentors others by sharing technical expertise and providing feedback and guidance. Resolves underlying problems. Identifies full range of customer/client needs and proposes solutions to address them; makes alterations in products or services to better meet (recognized or unrecognized) customer need.
- Directs the efforts of others such as technicians and outside resources. Performs tasks such as writing Capital Project Proposals, Standard Operating Procedures (SOPs), safety/quality checklists and job aids, scope documents, etc. Works with the Validation team to develop and execute validation protocols.
- Follow the Change Management process. This includes developing and presenting change requests, assuring that tasks required for the change are executed and completed per plan, and closing out change requests.
- Interacts with vendors to source new consumables facilitating fit activities, streamline the process, and improve safety.
Qualifications
- A Bachelors Degree in Engineering, science or closely related discipline is desired, or equivalent technical experience plus demonstrated competence, with a desired 2+ years of significant engineering and/or operational experience. Additional post-graduate education may contribute towards the desired years of experience.
- Has demonstrated competency within a discipline.
- Possesses a working technical knowledge and application of concepts, practices, and procedures. Ability to work on problems of moderate scope where analysis of situations or data requires a review of identifiable factors. Demonstrates judgment within defined procedures and practices to determine appropriate action.
- Interacts well with diverse groups within engineering and maintains strong working relationships with internal and external collaborators.
- Listens to and understands others' points of view and articulates tactfully and respectfully one's own perspective orally, in writing, and in presentations.
- Works well with other engineers in a collaborative, fast-paced goal-driven environment.
- Possesses interpersonal skills to negotiate and reconcile differences.
- Has a technical background in health care, medical devices, pharmaceutical, biologics, or similar industries (preferred).
- Has experience in the development or manufacturing of antibody drug conjugates (preferred)
- Has experience with the use of single use consumables (preferred).
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 this posting 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 short-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 and until 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, 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.
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