Validation Specialist

Key Responsibilities

• Perform validation activities for Syringe Assembly Machines, including installation, operational, and performance qualification (IQ, OQ, PQ).
• Develop, review, and execute validation protocols and reports in compliance with GMP standards.
• Troubleshoot and resolve equipment-related issues during validation activities.
• Collaborate with cross-functional teams, including Engineering, Quality Assurance, and Manufacturing, to ensure successful validation.
• Maintain detailed and accurate documentation in accordance with regulatory requirements.
• Support continuous improvement initiatives to optimize equipment performance and compliance.

Qualifications

• Minimum of 2 years' experience in the validation of Syringe Assembly Machines or equivalent equipment in a GMP pharmaceutical environment.
• Solid understanding of Validation Life Cycle documentation, including risk assessments, protocols, and reports.
• Familiarity with regulatory standards such as FDA, EU GMP, and ISO guidelines.
• Strong analytical, problem-solving, and communication skills.
• Ability to work independently and as part of a team to meet project deadlines.

Preferred Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related field.
• Experience with automated manufacturing equipment in sterile environments.

Compensation

Competitive hourly rate based on experience.