Senior Manager Clean Environments

Regeneron Pharmaceuticals • Rensselaer, IN

6d • $126,300 - $206,100 • Onsite

About The Position

Regeneron is seeking a Senior Manager, Clean Environments to lead HEPA filter, clean environment equipment, and cleanroom certifications, including compliance and contract and project management. The role oversees the day-to-day operations of the Clean Environment Certifications Group, including staff leadership and resource management, to maintain validated equipment and support production.

Requirements

• BS/BA in Engineering, a scientific field, or a related field; Engineering is preferred.
• 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.
• Ability to wear full cleanroom attire, which may include laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves, and use of sanitizing agents such as IPA during gowning.
• Ability to remove jewelry, make-up, and nail adornments when wearing cleanroom attire.

Nice To Haves

• 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.

Responsibilities

• 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 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; manage contractors on the approved supplier list.
• Perform Area Manager duties, ensure timely completion of clean environment certification quality investigations, and act as a subject matter expert during regulatory inspections.
• Handle employee and 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 subject matter expert when presenting to auditors.
• Interface with Quality Assurance, Quality Control, Manufacturing, and other functional areas to resolve conflicts and facilitate critical quality system decisions.
• Ensure compliance with GMP and Federal, State, and Local regulations, as evidenced by internal audits and government agency inspections.
• Monitor and maintain scheduled and on-demand certifications for clean rooms and clean environment equipment, and lead development of related policies and procedures.

Benefits

• Competitive and comprehensive total rewards package, which may include annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, medical, dental, vision, life and disability insurance, paid time off, and family support benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior