Senior Engineering Manager: GMP Sterilization & Operations

PEAK Technical Services Inc.; Branchburg Township (NJ); On-site; USD 150,000 - 210,000; Full time

Job summary

PEAK Technical Services Inc. is seeking a Senior Engineering Manager in Branchburg, NJ to lead the engineering team responsible for safe, reliable sterilization operations in a GMP environment. You will collaborate with Operations, Quality, and R&D to validate and maintain sterilization systems while driving continuous improvement.

The role demands hands-on leadership, strong communication, and the ability to balance immediate operational needs with strategic planning in a regulated setting.

Qualifications

• The role requires a Bachelor's degree in Engineering and 10+ years of GMP‑regulated experience, with sterilization experience preferred.
• 3–5+ years in leadership or supervisory roles managing technical teams and capital projects.
• Experience with equipment qualification, process validation, revalidation and change control.
• Strong understanding of sterilization technologies, cGMP regulations, and quality systems.

Responsibilities

• Direct, supervise, and develop the engineering team to meet objectives and performance expectations.
• Lead engineering support for troubleshooting, root cause analysis, and equipment performance within process parameters.
• Oversee calibration, preventive maintenance, qualification, validation, and requalification in GMP context.
• Maintain documentation aligned with Quality Management System.
• Plan and execute capital projects for equipment upgrades, facilities, and capacity expansion.
• Maintain cross functional collaboration with Operations, Quality, and R&D.
• Provide engineering input during internal, customer, and regulatory audits.
• Promote continuous improvement, accountability, and technical rigor while ensuring safety and efficiency.
• Ensure activities comply with quality standards, policies and procedures.

Skills

Leadership

GMP compliance

Root cause analysis

Project management

Equipment qualification

Process validation

Change control

Cross-functional collaboration

Documentation

Communication

Analytical skills

Troubleshooting

Hands-on leadership

Capital projects

Education

Bachelor's degree in Engineering

Job description

PEAK Technical Services Inc. is seeking a Senior Engineering Manager in Branchburg, NJ to lead the engineering team responsible for safe, reliable sterilization operations in a GMP environment. You will collaborate with Operations, Quality, and R&D to validate and maintain sterilization systems while driving continuous improvement.

The role demands hands-on leadership, strong communication, and the ability to balance immediate operational needs with strategic planning in a regulated setting.