C&Q Engineer, Lead

Ultimate Solutions • Columbus, OH

3d • Onsite

About The Position

The Commissioning and Qualification (C&Q) Lead will join a highly technical team for a start-up manufacturing site. They are responsible for overseeing and executing C&Q activities for facilities, utilities, systems, and equipment to ensure compliance with regulatory requirements and company standards. This role involves planning, coordinating, and managing C&Q efforts across capital projects or ongoing operational improvements. The Ultimate Team is in charge of the commissioning and qualification of several fully automated packaging lines for biotech drug product.

Requirements

• BS in Science or Engineering
• Minimum 10 years of related experience
• Packaging validation equipment experience, (biotech drug product, pharmaceutical, medical device) of different vendors and preferably will have experience working in any of the client’s sites worldwide.
• Strong leadership and people management skills.
• Availability to work in different shifts, extended shifts and weekends as required.
• Able to work with minimum or no supervision.
• Strong verbal & written communication skills in English.
• Must possess the ability to multi-task
• Must possess the ability to work under pressure.
• Ability to understand complex problems and to collaborate and explore alternative solutions.
• Ability to understand opposing points of view on highly complex issues and to negotiate and integrate different viewpoints.
• Ability to compose letters, outlines, and basic reports and/or to orally communicate technical information.

Nice To Haves

• Experience working in any of the client’s sites worldwide.

Responsibilities

• Manage the technical aspect of each line, provide support to the packaging engineering team and be responsible for packaging equipment validations.
• Manage the rest of the team working in the line, leading the team to the successful execution of validation activities.
• Communicate with the PM to maintain the entire project metrics.
• Implement packaging validation standards on a daily basis.
• Assure that policies and procedures are implemented to validate/qualify equipment, systems, and processes in accordance with regulatory requirements and company manufacturing standards.
• Review, complete, and approve regulatory documentation.
• Communicate with the staff and management on ways of implementing plans and recommendations.
• Assure project deliverables are done in a timely manner.

What This Job Offers

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