Senior Engineering Manager

Title: Senior Engineering Manager

Location: Branchburg, NJ

Status: Direct Hire

Experience: 10+ years of GMP experience

Summary

The Senior Engineering Manager leads the engineering team that supports the safe, reliable, and compliant operation of sterilization equipment and processes within a GMP‑regulated environment. This role is central to keeping equipment, facilities, and processes running smoothly while ensuring that every batch meets the quality and regulatory standards required for products that ultimately reach patients.

Working closely with Operations, Quality, and R&D, the Senior Engineering Manager oversees the technical aspects of sterilization technologies utilizing chlorine dioxide and ensures that systems are properly validated, maintained, and continuously improved. A big part of the job is helping the team troubleshoot issues, strengthen processes, and plan for facility upgrades or future capacity needs.

This position calls for someone who is hands‑on, approachable, and comfortable balancing immediate operational needs with strategic planning. The Senior Engineering Manager should bring strong communication skills, sound technical judgment, and the ability to lead teams through complex challenges in a GMP setting. Above all, this leader helps create an environment where engineering, quality, and operations work together to deliver consistent, compliant, and dependable sterilization performance.

Responsibilities

• Direct, supervise, and develop the engineering team to ensure effective performance and professional growth – manage ongoing projects list, priorities, and performance expectations aligned with departmental and organizational objectives.
• Lead engineering support for troubleshooting, root cause analysis, and equipment performance meets established process parameters, throughput requirements, and quality standards.
• Oversee calibration, preventive maintenance, qualification, process validation and requalification of equipment, while ensuring all engineering activities comply with GMP regulations, internal quality standards, and applicable regulatory requirements.
• Review and maintain accurate and complete documentation in alignment with Quality Management System.
• Lead and assist VP of Engineering with planning, execution, and completion of capital projects related to equipment upgrades, facility enhancements, and capacity expansion.
• Maintain Cross Functional Collaboration with Operations, Quality and R&D to support production needs and resolve technical issues with all equipment and processes.
• Provide engineering expertise during internal audits, customer audits, and regulatory inspections.
• Promote a culture of continuous improvement, accountability, and technical rigor while maintaining focus to enhance process capability, equipment reliability, and operational efficiency.
• Ensure engineering activities are performed in a safe, efficient and productive manner which comply with all quality standards, company policies and procedures.
• Execute additional responsibilities, as assigned to support departmental and organizational objectives.

Qualifications

• Bachelor's degree in Engineering (Mechanical, Chemical, Electrical, Industrial, or related field required).
• Minimum 10 years of engineering experience in a GMP‑regulated environment; sterilization experience strongly preferred.
• 3–5+ years of leadership or supervisory experience managing technical teams and demonstrated experience leading capital projects and facility or equipment upgrades.
• Experience with equipment qualification, process validation, revalidation and change control processes.
• Strong understanding of sterilization technologies and their operational requirements.
• In‑depth knowledge of cGMP regulations and quality system expectations within regulated manufacturing environments.
• Understanding of safety and environmental regulations related to sterilization operations.
• Demonstrated effective leadership skills with the ability to guide, mentor, and develop engineering teams to complete multiple tasks in a fast‑paced highly regulated environment.
• Strong analytical and troubleshooting abilities with a practical, hands‑on approach.
• Excellent communication skills, including the ability to convey technical information clearly to cross‑functional teams.
• Strong organizational skills with attention to detail and documentation accuracy.
• Demonstrated ability to work independently as well as collaborate effectively with cross‑functional teams to drive projects to completion.
• Outstanding verbal and written communication skills with experience in full Microsoft Office suite.
• Dependable, punctual and committed to maintain a positive attitude and strong work ethic.