TotalTek Engineering

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Client Overview:
Our client is responding to the COVID-19 pandemic through supporting our client's vaccine and diagnostic programs.
We are looking for a Senior Quality Validation Engineer. The Senior Validation Engineer will lead to process validation, cleaning validation, and equipment validation for the manufacturing facilities to meet current GMP and industry standards.

TotalTek is a Technology Company focused on managed services specializing Engineering and IT solutions.  We are a minority owned company with onshore and offshore capabilities that originated in northeast Wisconsin. Our workforce solutions and customized delivery in Project Outsourcing, Managed Resource Program and Staff Augmentation have expanded our capabilities to better serve companies in these niche industries. Our core value is Improving Lives for Clients and Consultants alike and is why we believe TotalTek is a simple solution to your complex Engineering and IT problems.

Position Summary:
Sr. Quality Validation Engineer  This is a direct hire role.

Responsibilities:

  • Responsible for performing manufacturing processes validation, cleaning validation, and equipment validation. This includes developing validation master plans preparing protocols, analyzing test results, and preparing technical reports
  • Coordinates validation activities with, and seeks team support from, Project Management, Manufacturing, Engineering, Quality, third Parties, and other groups on validation projects to ensure validation projects are carried out on time and on budget
  • Review and approve proposed changes for products by performing risk assessments, providing guidance and support, and assessing the adequacy of verifications and validations
  • Maintains up-to-date knowledge of validation requirements, practices, and procedures across the industry
  • Mentor and coach engineering, manufacturing, and quality personnel on the best practices for validations
  • Demonstrates excellent interpersonal skills, including the ability to resolve conflicts using poise, diplomacy, and tact and the ability to interact with people of a wide variety of backgrounds, levels of responsibility, and education levels
  • Complies with Health, Safety and Environmental responsibilities applicable to the position
  • Manage validation records in an electronic database system
  • Support client audits as needed
  • Assure compliance with all in-house or external specifications to standards, such as ISO and GMP regulations
  • Perform other duties as assigned

Qualifications:

  • BS Degree or equivalent in a scientific discipline.
  • Quality professional with a minimum of 8 years of relevant experience in a life science industry, including 5 years in process and cleaning validation
  • Requires knowledge of FDA regulated biotechnology or drug validation requirements (e.g., 21 CFR 210, 211 or 21 CFR 820 or ICH Q7)
  • Experience executing validation projects for biotech or pharmaceutical production projects
  • Must have specific knowledge of validation methodologies and principles
  • Strong technical writing and analytical skills
  • Expertise in risk management and application of FMEAs to validations
  • Understand mRNA, pDNA manufacturing process a plus

Travel:
•            Occasional (up to 10%) travel may be required based on business need.

COVID Information:
Our client is committed to the safety of their employees.  Currently, all employees are working remotely.  They are preparing for an eventual return to the office following CDC recommended safety measures.   

All Qualified Applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, or veteran status.  Qualified Applicants are United States Citizens or Permanent Residents (Green Card Holders) who have the legal right to work in the United States without sponsorship and meet the Minimum Qualifications listed above.
 

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