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

Description
The Senior Validation Engineer will perform, and support projects validation activities related to Systech software following the client’s processes and procedures.

Education:

•    Bachelor’s degree in Science or Engineering
•    Minimum 6 years of related experience

Responsibilities:

• Provide support to the Commissioning and Qualification (C&Q) team and will be responsible for Systech Software validations.
• The successful candidate supports packaging equipment project field executions, must be available to work in different shifts, be able to validate/qualify equipment and systems, and generate and complete validation protocols (Traceability matrix, IQ, OQ, Summary, among others).
• Demonstrate 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.
• Implement and follow policies and procedures to validate/qualify equipment, systems, and processes in accordance with regulatory requirements and company manufacturing standards.
• Prepare, execute, review, and maintain accurate, complete, and timely validation documentation using a right-the-first-time approach to support inspection readiness and minimize deviations and nonconformances. 
• Communicate with cross-functional teams and management on ways of implementing plans and recommendations.
• Assure project deliverables are done in a timely manner.
• Show initiative, adaptability, and willingness to take on additional responsibilities to support project success and organizational growth.

Requirements and Skills:

• Packaging validation equipment experience, (biotech drug product, pharmaceutical, medical device.
• Experience in Computer System Validation (CSV), including validation of serialization and track-and-trace platforms. Hands-on experience with Systech is preferred; however, candidates with experience in other platforms (e.g., OPTEL, Antares Vision, TraceLink, Cognex, Keyence, or equivalent serialization, track-and-trace, or vision inspection systems) used in regulated manufacturing environments will also be considered.
• Technical writing
• Able to work with minimum or no supervision.
• Strong interpersonal and teamwork skills with the ability to collaborate effectively in cross-functional environments. 
• Basic project management and reporting skills.
• Strong verbal and written communication skills in English.
• Willing to travel within the US & Internationally, including the ability to travel out of state on short notice.
• Availability to work flexible schedules, including multiple shifts, extended hours, weekends, and overtime, based on project demands. 

Physical Requirements:

• This role might at times require standing for prolonged periods of time and the ability to bend or stand on a stool as necessary. 
• Able to work safely and follow all company safety policies and procedures.

⚠️ Employment visa sponsorship is not available.
⚠️ Not open for Corp-to-Corp arrangements.
 

Ultimate Solutions USA, LLC is an equal opportunity employer. The company prohibits discrimination and harassment of any type and affords equal opportunity 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.