USA - Validation Specialist III (Engineering) (contract)

卡湯晩; Swiftwater (Monroe County); On-site; USD 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a Validation Specialist III to join their FLEXT Direct program. This dynamic role involves authoring and approving validation documents, developing cleaning cycles, and conducting data analysis in the biologics and vaccine sector. The ideal candidate will have a strong background in cleaning validation and a collaborative spirit, ready to contribute to impactful healthcare solutions. This position offers an exciting opportunity to work in a fast-paced environment, making significant contributions to the field of healthcare.

Qualifications

• 2+ years of experience in the biologic, vaccine, or pharmaceutical industry.
• Expertise in cleaning validation within the biologics or vaccine industry.

Responsibilities

• Authoring, reviewing, executing, and approving validation documents.
• Developing cleaning cycles and leading investigations.
• Analyzing data related to cleaning validation.

Skills

Documentation systems for protocol and report authoring

Collaborative team environments

Communication skills (verbal and written)

Microsoft Word

Microsoft Excel

Microsoft Outlook

MS Project

E Doc/GEODE+

Root cause analysis

cGMP experience

Education

BS/MS in Science (Chemistry, Biochemistry)

Engineering (Chemical or Biochemical)

Tools

Microsoft Word

Microsoft Excel

Microsoft Outlook

MS Project

E Doc/GEODE+

Job description

Job Summary

Join Sanofi's contingent workforce program, FLEXT Direct, as a Validation Specialist III for a 7-month contract. We are seeking an experienced individual with expertise in cleaning validation within the biologics or vaccine industry. The role involves authoring, reviewing, executing, and approving validation documents, developing cleaning cycles, analyzing data, and collaborating effectively with the Quality organization.

Responsibilities

• Authoring, reviewing, executing, and approving validation documents
• Developing cleaning cycles and leading investigations
• Analyzing data related to cleaning validation
• Determining acceptance criteria and sampling plans
• Conducting rinse and swab sampling
• Understanding bracketing and worst-case scenarios
• Managing QC testing requirements
• Knowledge of dirty hold times and clean hold times
  
  
  

Skills

• Proficiency in utilizing documentation systems for protocol and report authoring
• Experience working in collaborative team environments
• Strong communication skills (verbal and written)
• Proficient in Microsoft Word, Excel, Outlook, and MS Project
• Familiarity with E Doc/GEODE+ for templates, workflows, and approval processes
• Ability to conduct root cause analysis with cGMP experience
  
  
  

Qualifications

Education:

• BS/MS in Science (e.g., Chemistry, Biochemistry) or Engineering (Chemical or Biochemical)
• 2+ years of experience in the biologic, vaccine or pharmaceutical industry
  
  
  

This is an exciting opportunity to be part of a dynamic team at Sanofi's FLEXT Direct program. If you are looking to utilize your expertise in validation within the biologics or vaccine industry while working collaboratively in a fast-paced environment, this position is perfect for you. Join us in making a difference in healthcare through your contributions as a Validation Specialist III.