Process Validation Specialist

Job Title : Process Validation Specialist

Location : Marietta PA

Duration : 10 Months

Shift Details : 100% Onsite

Specific Skills :

Validation, Process Validation, Cleaning Validation, Material Qualification, Pharmaceutical, Manufacturing, cGMP, Regulatory Compliance, Process Monitoring

Top 3 Skills:

• Support design, technical transfer, and qualification of incoming materials, including chemicals and single-use systems (SUS).
• Validate and monitor manufacturing and cleaning processes.
• Execute process validation and incoming material qualification activities.

Job Description Details:

Support the development, validation, optimization, and maintenance of robust manufacturing processes within a vaccine production facility.

The role focuses on ensuring process efficiency, consistency, and compliance with regulatory and quality standards. Responsibilities include new product introduction, technical transfers, validation lifecycle activities, troubleshooting, continuous improvement, and cross-functional collaboration.

Key responsibilities include:

• Support design, technical transfer, and qualification of incoming materials, including chemicals and single-use systems (SUS).

• Validate and monitor manufacturing and cleaning processes.

• Support Continued Process Verification (CPV) and Cleaning Verification (CV).

• Monitor critical process parameters and manufacturing process parameters.

• Perform process confirmations to ensure Product Control Strategies are in place.

• Analyze process data and trends to identify improvement opportunities and reduce variability.

• Execute process validation and incoming material qualification activities.

• Support validation lifecycle maintenance and cleaning validation.

• Support Periodic Product Reviews and Validation Plans.

• Support manufacturing investigations, troubleshooting, deviation management, and process improvement.

• Provide technical support for corporate, customer, and regulatory audits.

• Support compliance with regulatory requirements and GSK standards.

• Develop standardized training materials and provide technical training as required.

• Collaborate with MSAT subject matter experts and Operations, Quality, and Engineering teams.

Minimum Education:

Bachelor Degree of Science, Post Graduate Degree of Science, or equivalent experience in a related scientific or technical discipline such as Chemical Engineering, Biological Engineering, Pharmacy, or Pharmaceutical Engineering.

Preferred Education:

Master Degree of Science or PhD.

Minimum Level of Job-Related Experience:

Minimum of 2–5 years of vaccine pharmaceutical process and/or validation experience, preferably within a multinational organization.