Ultimate Solutions is a trusted provider of packaging industrial automation, serialization, and regulatory compliance for the life science industries. Over 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. This opportunity will be on-site and will require to relocate in the United States.

 

DESCRIPTION

The Senior Validation Engineer will join a team that will manage the commissioning and qualification of several equipment of fully automated packaging lines for biotech drug products. The Sr.Validation  Engineer reports to the Ultimate Solutions C&Q Lead or Characterization Lead.  Also oversee and provide guidance to the Jr. Validation Engineer. Will be directly accountable for coordinating all activities through the client leads.  In addition, the Senior Engineer is responsible for the following project activities:

  - Applicable C&Q and Characterization documentation development and execution.
  - Support Characterization activities and recipe parameter optimization
  - Establish open communication with client's project coordinator and related team.
  - Participate in project meetings (as necessary).
  - Submit status reports.  

 

EDUCATION

• BS in Science or Engineering
• Minimum 6 years of related experience

 

​RESPONSIBILITIES

• The Senior Engineer will provide support to the packaging engineering team and will be responsible for packaging equipment validations.
• The successful candidate will also support packaging equipment project field executions, must have the availability to work in different shifts, be able to validate/qualify equipment and systems, and generate and complete validation protocols (Traceability matrix, IQ, OQ, PQ, among others).
• 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
• Implement policies and procedures to validate/qualify equipment, systems, and processes in accordance with regulatory requirements and company manufacturing standards
• Generate, execute, review, and complete regulatory documentation
• Communicate with the staff and management on ways of implementing plans and recommendations.
• Assure project deliverables are done in a timely manner
• Travel US & International up to 25%
• On-site job

 

REQUIREMENTS/SKILLS

• Packaging validation equipment experience, (biotech drug product, pharmaceutical, medical device)
• Available to work different shifts
• Technical writing
• Willing to work overtime including weekends depending on the nature of work available
• Able to work with minimum or no supervision
• Strong interpersonal skills and must work in a team
• Basic project management and reporting skills
• 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.

 

Ultimate Solutions 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.