Senior Manager Clean Environments

Regeneron Pharmaceuticals; Rensselaer (IN); On-site; USD 126,000 - 206,000; Full time

Job summary

Regeneron Pharmaceuticals is seeking a Senior Manager, Clean Environments in Rensselaer, NY. You will lead the HEPA filter and cleanroom certification program, manage staff and contractors, and ensure compliance with GMP and regulatory standards.

You will oversee budgeting, project management, and audits while coordinating with QA/QC/Manufacturing to keep production in a validated state. Strong leadership and 8+ years in related fields are required.

Qualifications

• BS/BA in Engineering or related field; 8+ years of engineering, facilities, manufacturing, and/or project management experience
• Excellent analytical, negotiation, and influencing skills
• Gowning and cleanroom attire requirements applicable to clean environments

Responsibilities

• Manage Tech Ops Clean Environment Certifications teams and outside contractors to maintain equipment in a validated state supporting the production schedule and routine certification of clean environments
• Plan departmental staffing patterns and operating expenses, and direct, train, and evaluate staff
• Oversee contracts for day-to-day activities and projects, including planning, budgeting, design, and project management, and manage suppliers on the approved list
• Perform Area Manager duties and lead quality investigations, acting as SME during regulatory inspections
• Handle employee relations including performance management, hiring, discipline, and retention while fostering a safe culture
• Lead GMP quality event investigations and CAPAs from initiation to closure, presenting to auditors as SME
• Interface with QA, QC, Manufacturing to resolve conflicts and support quality system decisions
• Ensure GMP, Federal, State, Local regulations are followed, evidenced by audits and inspections
• Monitor and maintain all scheduled and on-demand certifications for clean rooms and equipment; develop related policies

Skills

Analytical skills

Negotiation

Influencing others

Education

BS/BA in Engineering or related field

Job description

Build our future together:

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Manager, Clean Environments to lead all aspects of HEPA filter, clean environment equipment, and cleanroom certifications, including compliance and management of contracts and projects. In this role, you will oversee day-to-day operations of the Clean Environment Certifications Group, including staff leadership and resource management. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & where:

• Location: Rensselaer, New York, United States
• Work model: Onsite, Monday-Friday, 8:00am-4:30pm

Discover your role:

• Manage Tech Ops Clean Environment Certifications teams and outside contractors to maintain equipment in a validated state supporting the production schedule, and support routine certification of clean environments in compliance with governing SOPs
• Plan departmental staffing patterns and operating expenses, and direct, train, and evaluate both exempt and non-exempt employees assigned to the function
• Oversee contracts for day-to-day activities and projects, including project planning, budgeting, design, and project management, and manage contractors on the approved supplier list
• Perform Area Manager duties, ensuring timely completion of clean environment certification quality investigations, and act as subject matter expert during regulatory inspections
• Handle all aspects of employee/labor relations, including performance management, hiring, discipline, and retention, while fostering a safe work culture
• Lead GMP quality event investigations and associated CAPAs from initiation through closure, and serve as the lead SME when presenting to auditors
• Interface regularly with Quality Assurance, Quality Control, Manufacturing, and other functional areas to resolve conflicts and facilitate critical quality system decisions
• Ensure GMP, Federal, State, and Local regulations are followed, as evidenced by internal audits and government agency inspections
• Monitor and maintain all scheduled and on-demand certifications for clean rooms and clean environment equipment, and lead development of related policies and procedures

This role requires:

• BS/BA in Engineering, scientific, or related field (Engineering preferred) and 8+ years of engineering, facilities, manufacturing, and/or project management experience, or an equivalent combination of education and experience
• Excellent analytical, negotiation, and influencing skills
• Gowning and Physical Requirements:
• Full cleanroom attire (examples may include including laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves and the use of sanitizing agents during gowning process including IPA)
• Ability to remove jewelry, make-up and nail adornments when wearing cleanroom attire is required
• Preferred Qualifications:
• 5+ years of experience operating a clean environment certification program
• 5+ years of experience in a pharmaceutical or other cGMP environment
• 5+ years of experience in a leadership role

We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

$126,300.00 - $206,100.00