Tech Transfer Process Validation Scientist

Role:Tech Transfer & Process Validation Scientist

Location: Greenville, NC

Employment Type: Contract (6 Months, with potential extension)

• Support technology transfer and process validation activities for new pharmaceutical projects within a CDMO environment.

• Lead and execute technology transfer activities for sterile drug products and aseptic fill-finish operations.

• Develop, execute, and review process validation and Process Performance Qualification (PPQ) protocols.

• Perform data assessment, technical evaluations, and prepare final validation reports.

• Assess manufacturing readiness and identify and resolve technical gaps.

• Collaborate with cross-functional teams, including MSAT, Manufacturing, Quality, and Engineering.

• Provide technical expertise throughout technology transfer and process validation activities.

• Prepare and review technical documentation while ensuring compliance with applicable GMP requirements.

• Independently manage assigned technology transfer and validation activities.

• 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 experience in 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.

• Experience collaborating with MSAT, Manufacturing, Quality, and Engineering teams.

• Excellent technical writing, communication, and problem-solving skills.

• Ability to work independently and manage technology transfer projects.

Anticipated hourly pay range: $50 $52 per hour on W-2.

Employees hired into this position are eligible for the following benefits, subject to the applicable plan terms and eligibility requirements:

Health Insurance:
Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for paying the full cost of their insurance premiums.

Retirement Benefits:
A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided.

Paid Time Off (PTO):
No PTO other than that required by applicable state and local laws.