Validation Engineer

About the Company

Stark Pharma Solutions Inc. is a global consulting and staffing partner established in 2014, serving the Pharmaceutical, Medical Device, Biotech, and IT industries across the USA, Canada, and India. We provide specialized consulting and staffing solutions across Quality & Validation, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Project Management, and IT, with a focus on delivering tailored solutions that drive growth, operational excellence, and long-term client success.

Responsibilities

• Support Process Validation, Cleaning Validation, and CQV activities.
• Prepare, review, and execute IQ/OQ/PQ and PPQ protocols.
• Prepare validation plans, protocols, and final reports.
• Support qualification of manufacturing equipment, facilities, and utilities.
• Support cleaning validation activities, including swab and rinse sampling.
• Perform residue limit calculations for cleaning validation.
• Support equipment installation, process improvements, and technology transfers.
• Work with Manufacturing, Quality Assurance, Engineering, MS&T, and Regulatory teams.
• Ensure validation activities comply with cGMP, FDA, and EMA requirements.
• Support OSD manufacturing processes including blending, granulation, compression, encapsulation, coating, and packaging.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, or a related field.
• Experience as a Validation Engineer in a pharmaceutical manufacturing environment.
• Experience with OSD manufacturing processes.
• Hands-on experience with Process Validation and Cleaning Validation.
• Experience with CQV and equipment qualification.
• Strong knowledge of IQ/OQ/PQ and PPQ.
• Experience with swab and rinse sampling and residue limit calculations.
• Knowledge of cGMP, FDA, and EMA requirements.
• Strong technical writing, communication, and problem-solving skills.