Validation Engineer

Validation Engineer –
SHINE Technologies

We are seeking a Validation Engineer to execute validation activities to ensure that systems, processes, and products meet specified requirements and regulatory standards. The role involves assisting in the development and execution of validation protocols, ensuring compliance with quality standards, and supporting therapeutic validation activities in the commercial manufacturing facility.

• Develop and implement validation strategies, create and maintain protocols and reports aligning with regulatory requirements.
• Lead the development of risk assessments related to validation activities.
• Ensure validation activities follow SHINE validation policies, procedures, and the Master Validation Plan.
• Coordinate and help execute approved protocols for process validation, equipment qualification (IQ/OQ/PQ), and requalification/revalidation of critical systems and utilities.
• Provide input and guidance on new and existing validation projects across facility systems, manufacturing equipment, processes, analytical instrumentation, and cleaning processes.
• Ensure validation initiatives adhere to specified timelines and deliver status reports for Management Review Meetings.
• Review FDA and EMA regulations to ensure validation activities meet defined requirements.
• Assist in documentation management: develop protocols, prepare reports, analyze data, write final reports, and support regulatory inspections.
• Perform periodic reviews of system validation and reporting for the Annual Quality Product Review and implement gap plans.
• Collaborate with development, manufacturing, quality, and other cross‑functional teams to align validation with project phases and timelines.
• Identify opportunities for improvement in validation processes and implement corrective actions.

• B.S. in Scientific Discipline or equivalent other work experience.
• 5+ years of validation experience within a pharmaceutical or medical device company.
• Experience in cGMP environments.
• Strong understanding of validation principles, methodologies, and regulatory requirements.
• Experience drafting and executing qualification documents (IQ, OQ, PQ).
• Ability to write procedures and protocols, review documentation, lead and motivate teams, manage projects, and communicate effectively.
• Ability to analyze data, identify risks, develop solutions, and resolve validation and compliance issues.
• Excellent written and verbal communication skills for interacting with cross‑functional teams and stakeholders.

Working Conditions and Physical Effort
Requires frequent leaning, bending, stooping, crouching, grasping, and reaching above the shoulders and below the knees. Moderate physical activity. Requires handling average‑weight objects up to 40 pounds or standing/walking more than four (4) hours per day. Fine motor coordination and strong depth perception are beneficial. Exposure to extreme temperatures, dust, fumes, smoke, odors, and loud noises may occur. Follow basic safety precautions.

Application Instructions
Apply Online:

Mid‑Senior level

Full‑time

Quality Assurance