Director of Operations

MKH Search; North Carolina; On-site; USD 150,000 - 210,000; Full time

Job summary

MKH Search is seeking an experienced High Purity Division Manager to lead a growing division responsible for design, installation, qualification, and ongoing operation of high purity systems for pharmaceutical and biotech manufacturing. This is a senior leadership role with full accountability for division performance, safety, compliance, and growth.

This hands-on leader will manage a multi-disciplinary team across engineering, operations, and quality, ensuring projects meet cGMP, FDA, and

Qualifications

• Bachelor's degree in Engineering (Mechanical, Chemical, or related field) or equivalent.
• Significant experience with high purity systems in pharma/biotech regulated manufacturing.
• Proven track record managing large teams (20+ reports) in engineering/operations.
• Strong knowledge of cGMP and IQ/OQ/PQ validation processes.

Responsibilities

• Provide strategic and operational leadership for the High Purity Division with P&L accountability.
• Lead and develop a division of 20–100+ engineers, technicians, and project managers.
• Oversee design, installation, commissioning, qualification, and validation of high purity systems.
• Ensure projects comply with cGMP, FDA, and regulatory standards.
• Partner with clients to scope projects, manage budgets, and timelines.
• Drive continuous improvement in engineering standards and safety practices.
• Build relationships with clients, contractors and regulators.
• Recruit and retain top engineering and operations talent.
• Report division performance and risks to senior leadership.

Skills

Leadership

P&L management

Budgeting

Regulatory knowledge

Client relationship mgmt

Travel willingness

Education

Bachelor's in Engineering

Advanced degree preferred

Job description

We are seeking an experienced High Purity Division Manager to lead a growing division responsible for the design, installation, qualification, and ongoing operation of high purity systems supporting pharmaceutical and life sciences manufacturing. This is a senior leadership position overseeing a large, multi-disciplinary team across engineering, operations, and quality functions, with full accountability for division performance, safety, compliance, and growth.

This role is ideal for a hands‑on operations or engineering leader who understands the technical demands of high purity water, gas, and process utility systems within a GMP‑regulated environment, and who is ready to build and scale a high‑performing team.

Key Responsibilities

• Provide strategic and operational leadership for the High Purity Division, including P&L accountability, resource planning, and long-term growth strategy
• Lead, mentor, and develop a division of 20-100+ engineers, technicians, project managers, and support staff across multiple sites or projects
• Oversee the design, installation, commissioning, qualification, and validation of high purity water, gas, and chemical distribution systems for pharmaceutical and biotech manufacturing clients
• Ensure all projects and operations comply with cGMP, FDA, and relevant regulatory and industry standards
• Partner with clients and internal stakeholders to scope projects, manage budgets and timelines, and ensure technical and commercial success
• Drive continuous improvement in engineering standards, safety practices, and operational efficiency across the division
• Build and maintain strong relationships with clients, contractors, and regulatory bodies
• Recruit, onboard, and retain top engineering and operations talent to support division growth
• Report on division performance, risks, and opportunities to senior leadership

What We’re Looking For

• Bachelor’s degree in Engineering (Mechanical, Chemical, or related field) or equivalent experience; advanced degree a plus
• Significant experience in high purity systems within pharmaceutical, biotech, or related regulated manufacturing environments
• Proven track record managing large teams (20+ direct/indirect reports) in an engineering, construction, or operations setting
• Strong working knowledge of cGMP, validation/qualification processes (IQ/OQ/PQ), and regulatory requirements for pharmaceutical manufacturing
• Demonstrated P&L, budget, and project management experience at a divisional or business unit level
• Excellent leadership, communication, and client relationship management skills
• Willingness to travel to client sites as required

What We Offer

• Competitive salary and performance‑based incentives
• The opportunity to lead and shape a growing division within a specialized, high‑demand sector
• A collaborative, technically driven culture with strong career development pathways