Ultimate Solutions is a trusted provider of packaging industrial automation, serialization, and regulatory compliance for the life science industries. For 20 years, the Ultimate team has delivered proven results in hundreds of projects and thousands of service hours to the global leaders of pharmaceutical, biotechnology, medical devices, and logistics markets.

Description:
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. 

Education:

• BS in Science or Engineering
• Minimum 10 years of related experience

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
• Must possess a solid understanding of FDA validation guidelines and industry best practices for this field and be able to 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

Requirements/Skills:

• 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
• Technical writing
• Availability to work in different shifts, extended shifts and weekends as required. Must also be able to travel out-of-state in short notice
• Able to work with minimum or no supervision
• Strong interpersonal and teamwork skills
• Advanced project management and reporting skill
• Strong verbal & written communication skills in English
• Applicants must be currently authorized to work for any employer in the United States on a full-time unrestricted basis. Employment visa sponsorship is not available
• Not open for Corp-to-Corp arrangements
• Ability to travel US & International up to 25%

Physical Requirements:

• Ability to work safely and follow all company safety policies and procedures.
• Ability to lift 2-20 pounds regularly, climb steps and ladders, and stand or walk for prolonged periods of time.

Addtional Requirements:

• 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
• Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions as outlined in the job description

Ultimate Solutions USA, LLC is an equal opportunity employer. The company prohibits discrimination and harassment of any type and affords equal employment opportunities to employees and applicants without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.