C&Q Lead

Job Title: C&Q Lead Location: Columbus, OH

Experience: 8 - 10 Years

Contract Duration: 12+ months (possible extension)

Position Summary

We are seeking a Commissioning & Qualification (C&Q) Lead to support the startup of a new manufacturing site. This role will lead the planning, execution, and oversight of C&Q activities for facilities, utilities, systems, and equipment to ensure compliance with regulatory requirements and company standards. The C&Q Lead will focus heavily on packaging equipment validation, coordinating cross-functional teams, and driving successful project delivery.

Education & Experience

Bachelor’s degree in Science, Engineering, or related field.

Minimum 8 years of C&Q or validation experience in life sciences.

Key Responsibilities

Lead technical activities for packaging lines, including equipment validation and support for packaging engineering.

Manage assigned team members to ensure validation deliverables are met.

Collaborate with project managers to track and maintain project metrics.

Apply FDA validation guidelines and industry best practices in daily operations.

Establish and maintain policies and procedures for equipment, system, and process qualification in compliance with GMP.

Review, complete, and approve regulatory documentation.

Partner with stakeholders to implement plans, resolve issues, and drive recommendations.

Ensure all project deliverables are completed on schedule and within scope.

Required Skills & Qualifications

Hands-on experience in packaging equipment validation for biotech, pharmaceutical, or medical device products across multiple vendor platforms.

Prior experience at global client sites preferred.

Strong leadership and people management capabilities.

Willingness to work different shifts, extended hours, and weekends as needed.

Ability to work independently with minimal supervision.

Excellent written and verbal communication skills in English.

Additional Competencies

Strong multitasking skills and ability to perform under pressure.

Analytical problem-solving with the ability to identify and implement solutions.

Skilled in navigating diverse perspectives and building consensus.

Proficient in preparing technical reports, documentation, and presentations.