Aseptic Process Validation Specialist at Fagron
Wichita, Kansas, USA -
Full Time


Start Date

Immediate

Expiry Date

28 Nov, 25

Salary

0.0

Posted On

28 Aug, 25

Experience

3 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Regulatory Requirements, Project Management Skills, Data Analysis, Technical Writing, Biotechnology Industry, Interpersonal Skills

Industry

Pharmaceuticals

Description

Who we are
Fagron is the global market leader in pharmaceutical medicine, and its products are sold to more than 200,000 customers in over 60 countries.
The goal of Fagron is: “Together we create the future of the personalized medicine”. Fagron, together with prescribers, pharmacists, and customers, strives to improve medications and help the patient.
From our position as market leader, we act locally and think internationally.
About the job
The Aseptic Process Validation Specialist is responsible for planning, executing, and overseeing aseptic process simulations (media fills) to ensure compliance with regulatory requirements and internal quality standards. The role involves coordinating cross-functional teams, documenting processes, analyzing results, and driving continuous improvement initiatives in aseptic operations.

QUALIFICATIONS

Education: High School Diploma

EXPERIENCE:

  • 3+ years of experience in aseptic manufacturing, quality assurance, or a related role within the pharmaceutical or biotechnology industry.
  • Hands-on experience with media fills, aseptic techniques, and sterile production environments.

SKILLS:

  • Strong knowledge of cGMP, FDA, and other relevant regulatory requirements.
  • Excellent organizational and project management skills.
  • Proficiency in data analysis and technical writing.
  • Effective communication and interpersonal skills for cross-functional collaboration.
Responsibilities

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