Sterile Tech Transfer & Process Validation Scientist

Novozen Healthcare LLC; Greenville (NC); On-site; USD 69,000 - 72,000; Full time

Benefits offered by this job

Health Insurance

401(k) retirement plan

PTO policy

Job summary

Novozen Healthcare LLC in Greenville, NC is seeking a Tech Transfer & Process Validation Scientist for a 6-month contract to support transfer activities andPPQ in a CDMO setting. The role emphasizes sterile products and aseptic fill-finish operations, requiring hands-on expertise and independent project management.

Responsibilities include developing and executing validation protocols, assessing manufacturing readiness, and preparing final reports while collaborating with MSAT, Manufacturing,

Qualifications

• 7+ years of experience in pharmaceutical manufacturing, technology transfer, and process validation.
• Strong experience with sterile drug products and aseptic fill-finish operations.
• Hands-on technology transfer within a pharmaceutical CDMO environment.
• Strong knowledge of process validation and PPQ activities.
• Experience in protocol development, execution, data assessment, and final reporting.
• Ability to assess manufacturing readiness and resolve technical challenges.
• Excellent technical writing, communication, and problem-solving skills.
• Ability to work independently and manage technology transfer projects.

Responsibilities

• Support technology transfer and process validation activities for new pharmaceutical projects in a CDMO environment.
• Lead and execute technology transfer for sterile drug products and aseptic fill-finish operations.
• Develop, execute, and review process validation and PPQ protocols.
• Perform data assessment, technical evaluations, and prepare final validation reports.
• Assess manufacturing readiness and identify and resolve technical gaps.
• Collaborate with MSAT, Manufacturing, Quality, and Engineering teams.
• Provide technical expertise throughout technology transfer and process validation activities.
• Prepare and review technical documentation ensuring GMP compliance.
• Independently manage assigned technology transfer and validation activities.

Skills

Process validation

Technology transfer

Sterile operations

Technical writing

Communication

Problem-solving

Job description

Novozen Healthcare LLC in Greenville, NC is seeking a Tech Transfer & Process Validation Scientist for a 6-month contract to support transfer activities andPPQ in a CDMO setting. The role emphasizes sterile products and aseptic fill-finish operations, requiring hands-on expertise and independent project management.

Responsibilities include developing and executing validation protocols, assessing manufacturing readiness, and preparing final reports while collaborating with MSAT, Manufacturing,