Equipment Engineer IV, Drug Delivery & Biomaterials
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.
The Engineer IV develops and scales up manufacturing equipment for biomaterials-based products for use in next generation medical aesthetics and implant products via equipment selection, design and operation to ensure a robust production process.
1. Under general direction, responsible for implementing complex materials engineering projects.
2. Actively works in a team environment. Frequent communication is essential and must interface with colleagues in Biomaterials Development, Analytical Services, Product Development, Commercial and Cell & Tissue areas. Will remain as “internal consultant” as technology moves into commercial manufacturing. May be responsible for supporting raw material efforts in choosing potential suppliers, qualifying incoming lots, developing proper analytical assays, and drafting of specifications.
3 .Organizes, schedules and participates in project team meetings to define and schedule project activities and review completed tasks.Communicates project status to supervisor, project team leader, other research managers, and R&D committees as appropriate. Prepares time and cost estimates of project activities for review by manager to achieve realistic project completion dates.
4. Attends and participates in scientific meetings as AbbVie’s representative to gain knowledge about new products or technologies pertinent to corporate business interest. Reviews and evaluates current technical and trade literature in order to maintain and extend technical competence. Communicates new compound, product, and technology related ideas to supervisor and other research managers to maintain and enhance AbbVie’s position in the marketplace.
5. Other activities (but not limited to) are as follows:
· prepares and justifies capital expenditure requests for procurement of laboratory equipment and instruments.
· interviews applicants, conducts performance appraisals, recommends personnel actions such as promotions, hiring etc.
· interacts with fellow staff colleagues in a way that adds to departmental optimal efficiency.
6. Writes, reviews and issues technical reports, technical memoranda and other documents for internal and external distribution. Generates ROI’s and works closely with AbbVie patent counsel in generating IP documentation.
7. Monitor group costs. Initiate personnel actions, including employee hires, promotions, transfers and discharges. Create and present employee evaluations, subject to the approval of the department Director. Assess subordinate employee training needs and conduct or recommend training as necessary. Administer employee disciplinary actions as the situation requires.
- B.S, M.S. or Ph.D. degree in Chemical Engineering, Materials Engineering, or related field. A minimum of 7+ (B.S), 4+ (M.S) or 0+ (Ph.D.) years industrial or post-graduate experience is a must.
- Experience in one or more of the following technology areas is essential: scale up from bench to pilot scale for clinical trials, large scale equipment for chemical synthesis, purification, and aseptic processing of solutions under GMP conditions including sterile filtration/mixing/syringe filling. Understanding and experience related to automated chemical reactors and scale up.
- Experience with managing installation, major modification, and commissioning of production equipment during capital expansion. Developing SOPs, training technicians, refining production parameters, and providing ongoing support.
- Thorough understanding and experience related to automated equipment for sterile filtration and mixing of solutions under GMP conditions.
- Support with and thorough understanding of design control documentation.
- Complete understanding and wide application of technical principles, theories, and concepts in the field. General knowledge of other related disciplines.
- Ability to manage various aspects of R&D from product concept to product launch.
- Ability to effectively present information and respond to questions from groups of managers or technical peer groups.
- Ability to comprehend and apply principles of advanced math and statistical theory (i.e. t-tests, f-tests, tolerance limits)
- Knowledge and working experience on implantable biomaterials, hydrogels are a plus.
- Ability to generate drawing for dimensions, tolerance and interfit investigations, and conformance to ANSI Y14.5.
- Understanding of the manufacturing scale up of equipment from bench to pilot scale as it relates to medical devices.
- Understanding and hands-on experience with large scale automated tangential flow filtration equipment under GMP conditions for the purification of polymer solutions.
- Understanding and hands-on experience with large scale automated filling of syringes/vials under ISO5 conditions.
Significant Work Activities
Job Level Code
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.