Tech Transfer / Cleaning / Process Validation

Job Overview:

We are seeking a highly motivated and detail-oriented Validation Specialist with at least 2 years of experience in the transfer of solid products, Packaging Processes Validation, and Cleaning Validation within the pharmaceutical manufacturing industry. The ideal candidate will have a strong understanding of regulatory requirements and quality standards, including cGMP (current Good Manufacturing Practices) and FDA guidelines.

Key Responsibilities:

Transfer of Solid Products:

• Plan and execute the transfer of solid dosage products between manufacturing sites or within departments.
• Coordinate with cross-functional teams to ensure seamless product transfers.
• Perform risk assessments and ensure compliance with regulatory requirements during the transfer process.

Validation of Packaging Processes:

• Develop and implement validation protocols for packaging processes.
• Conduct validation/qualification of packaging equipment.
• Ensure packaging systems maintain product integrity and compliance with stability studies and storage conditions.

Validation of Cleaning Procedures:

• Validate cleaning procedures for equipment used in the production of solid dosage forms to ensure compliance with regulatory and safety standards.
• Develop cleaning validation protocols, including sampling techniques, acceptance criteria, and analytical methods.
• Ensure proper documentation and reporting for all validation activities.

Compliance & Documentation:

• Maintain thorough and accurate documentation of all validation activities according to cGMP and regulatory requirements.
• Prepare validation reports and provide input into regulatory submissions as needed.
• Ensure compliance with FDA, EMA, and other relevant regulatory authorities.

Qualifications:

• Bachelor’s degree in Pharmaceutical Sciences, Chemical Engineering, or a related field.
• 2+ years of experience in the pharmaceutical manufacturing industry, specifically in solid product transfer, packaging process validation, and cleaning validation.
• In-depth knowledge of cGMP, FDA regulations, and industry guidelines related to pharmaceutical production and validation.
• Hands-on experience with validation protocols (IQ, OQ, PQ) and statistical analysis of validation data.
• Strong problem-solving skills, with attention to detail and the ability to manage multiple projects simultaneously.
• Excellent written and verbal communication skills for documentation and cross-functional collaboration.

Preferred Skills:

• Experience with solid oral dosage forms such as tablets or capsules.
• Proficiency in validation software or tools.
• Knowledge of Lean Manufacturing or Six Sigma principles.
• Familiarity with equipment such as tablet presses, blister packaging machines, and cleaning validation analytical techniques.