Job Summary:

The Validation Specialist will support process validation activities for a technology transfer project in a pharmaceutical manufacturing environment. This role involves developing technical documentation for change control and process validation, as well as performing sampling and handling in compliance with regulatory standards.

Key Responsibilities:

• Develop and execute process validation protocols (IQ, OQ, PQ) for technology transfer projects.
• Prepare and maintain technical documentation for change control, validation reports, and regulatory submissions.
• Conduct sampling activities in assigned areas, ensuring proper handling and documentation in a regulated environment.
• Collaborate with manufacturing, quality assurance, regulatory, and engineering teams to ensure validation compliance.
• Analyze validation data, identify trends, and recommend improvements to optimize manufacturing processes.
• Ensure compliance with GMP, FDA, and industry regulations related to validation activities.
• Support audits and inspections by providing validation documentation and technical expertise.
• Assist in troubleshooting and resolving validation-related issues during technology transfer.

Qualifications & Experience:

• Bachelor’s degree in Engineering, Life Sciences, or a related field.
• 3-5 years of experience in process validation within a pharmaceutical or regulated manufacturing environment.
• Strong understanding of GMP, FDA, and ISO regulations related to validation and technology transfer.
• Experience in change control documentation and validation lifecycle management.
• Hands-on experience with sampling techniques and regulatory handling procedures.
• Excellent analytical, problem-solving, and technical writing skills.
• Ability to work independently and collaboratively in a cross-functional team.

Preferred Skills:

• Knowledge of statistical analysis tools for validation data interpretation.
• Ability to operate specialized laboratory equipment and computers as appropriate.
• Ability to interpret and apply GLPs and GMPs.
• Familiarity with risk assessment methodologies in validation processes.

Work Methodology:

• Professional services contract
• 6-12 months of project assignment with potential extension
• Administrative shift Monday to Friday, 8am - 5pm with availability to support activities in non-standard hours
• On-site job