Validation Engineer OSD Manufacturing

About the role

Our client is seeking a hands-on Validation Engineer with 5–10 years of pharmaceutical manufacturing experience, including strong Oral Solid Dosage (OSD) manufacturing experience. The ideal candidate will be a self-directed validation generalist who can independently manage validation projects and work closely with operators on the manufacturing floor.

Responsibilities

• Develop and execute validation protocols for registration batches and process validation
• Support IQ/OQ/PQ execution and equipment validation activities
• Develop batch records, sampling plans, risk assessments, and related validation documentation
• Write deviations and support CAPA investigations and implementation
• Coordinate sampling materials, containers, labels, and in-room execution with Operations
• Perform validation activities on OSD equipment, including:
  • Tablet presses
  • Encapsulators
  • Fluid-bed dryers
  • Coaters
• Support technology transfer and process validation activities
• Perform hands-on validation activities on the manufacturing floor while completing required documentation and computer-based work
• Collaborate closely with Manufacturing, Operations, Quality, and Engineering teams

Required Qualifications

• 5–10 years of Validation Engineering experience in pharmaceutical manufacturing
• Strong Oral Solid Dosage (OSD) manufacturing experience is required
• Hands-on experience with tablet and capsule manufacturing equipment
• Experience developing and executing validation protocols
• Experience with IQ/OQ/PQ and equipment qualification
• Experience with batch records, sampling plans, and risk assessments
• Experience managing deviations and supporting CAPA investigations
• Strong understanding of GMP/cGMP requirements
• Self-directed with the ability to take ownership of projects with minimal supervision
• Comfortable working directly with operators on the manufacturing floor

Preferred Qualifications

• Cleaning Validation experience within OSD manufacturing
• Technology transfer experience
• Experience with process validation and registration batches
• Understanding of computerized systems from an equipment/validation perspective