Sr CSV Engineer

Description
The SeniorValidation Engineer will perform and support projects validation activities related to Systech software following the clients processes and procedures.

Education:

• Provide support to the Commissioning and Qualification (C&Q) team and will be responsible for SystechSoftware 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.

• 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 beconsidered.
• 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.

• 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.

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.