Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including oncology, rheumatoid arthritis, asthma, atopic dermatitis, pain, and infectious diseases.
Summary: Manages the design, specification, and installation of new and renovated biopharmaceutical process equipment. Provides engineering support and problem solving for existing equipment and manufacturing processes.
Essential Duties and Responsibilities include, but are not limited to, the following:
* Manages the scope, deliverables, schedule, budget and quality of engineering projects related to cGMP process equipment, piping, and controls.
* Responsible for preparation and presentation of project status reports.
* Manages the design review, site acceptance, and installation of equipment.
* Prepares Piping & Instrumentation Diagrams and other related drawings and documents.
* Supports QA/Validation Department through preparation of design documents and protocol review.
* Recommends and manages implementation of appropriate corrective/preventative actions for existing equipment and manufacturing processes.
* Evaluates, approves, prepares, and executes change control documentation.
* Acts as Subject Matter Expert during regulatory inspections and internal investigations.
* Supports Manufacturing and Maintenance activities as technical advisor.
* Supervises mechanical, electrical, automation, and engineering contractors.
* Maintains a clean and safe working environment by enforcing procedures, policies, and regulations.
* Maintains company reputation by enforcing compliance with local, state, and federal regulations.
Knowledge and Skills:
* Thorough knowledge of cGMPs and sanitary equipment design requirements.
* Working knowledge of process control systems and automation.
* Advanced knowledge of engineering documentation required for cGMP process equipment.
* Substantial knowledge of clean room design & function and biopharmaceutical equipment.
* Strong written and oral communication skills.
* Solid supervision, leadership, and project management skills.
* Ability to understand and manage project plans, budgets, and schedules.
* Working knowledge of word processing, spreadsheets, database management software, CAD software, and PCs.
Education and experience:
* Requires BS/BA or higher in chemical or biochemical engineering with 7+ years of experience in equipment process engineering. Direct experience with biopharmaceutical process equipment and formal training in project management is preferred. May substitute relevant experience for education.
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.
To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.