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 markets medicines for eye diseases, colorectal cancer, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including hypercholesterolemia, oncology, rheumatoid arthritis, allergic asthma, and atopic dermatitis.
Primarily responsible for the GMP manufacturing facility lifecycle and operations within, including but not limited to: planning, finance, budget development, design, construction management, startup, validation, regulatory compliance, maintenance, procurements, outside service contracts, permits, safety, calibrations, daily operations, new product development, manufacturing and commercialization.
Essential Duties and Responsibilities include, but are not limited to, the following:
- Provide management and technical consultation to employees, contractors, and consultants across the Rensselaer site in the support of engineering, utilities, maintenance, CAPEX, and facilities/manufacturing related projects, contracts and ongoing operations;
- Plan annual engineering/facilities budget and develop/negotiate contracts with service providers;
- Manage multiple concurrent capital projects;
- Responsible for all aspects of planning and executing projects, in consideration of GMP regulatory Compliance and EH&S expectations;
- Develop CAPEX proposals and 5-year capital improvement plan;
- Direct cross-functional teams to meet manufacturing needs;
- Resolve technical problems during design phase to limit construction change orders;
- Serve as Subject Matter Expert in site utilities, including but not limited to HVAC, Purified Water, Electrical Systems (Utility, Generator and UPS), Compressed Air, Nitrogen, Chilled Water, Heating Hot Water, Steam/Condensate and Sewer; - Develop and update SOPs related to new and existing systems;
- Participate in development and commercialization of new technologies.
Knowledge and Specialized Skills:
- Ability to work independently and within teams to identify and resolve issues associated with the ongoing operations;
- Demonstrated flexibility in organizing work and priorities;
- Strong interpersonal, oral, and written skills;
- Good understanding of word processing, spreadsheet, and database management software.
Education and Experience:
- BS in Engineering required
- Minimum 10 years of engineering, maintenance, manufacturing, and project management experience in the Biopharmaceutical industry required;
- Minimum 5 years of experience in maintaining regulatory compliance through audits, validation, change management, risk assessments, qualified drawings, corrective action plans, FMEA, and deviation support;
- Building Management System (BMS) and Environmental Management System (EMS) experience.
*Title level (Associate Manager, Manager, or Sr. Manager) will be determined based on skills and experience.
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 recruitment agencies:
Regeneron is using the agency management company, Candex - www.candex.com. 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 without a valid written search firm agreement in place for this position will be deemed the sole property of Regeneron. No fee will be paid in the event the candidate is hired by Regeneron as a result of the referral or through other means.
Regeneron is an equal opportunity employer and is an affirmative action employer.
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