Validation Engineer

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SHINE Technologies is seeking a Validation Engineer to execute validation activities ensuring systems, processes and products meet specified requirements and regulatory standards. The role involves developing and executing validation protocols, ensuring compliance to quality standards and regulations, and supporting therapeutic validation activities in the commercial manufacturing facility.

The base salary range for this position is $75,000 - $90,000 per year plus a comprehensive compensation package.

• Developing and implementing validation strategies.
• Create and maintain validation protocols and reports, ensuring they align with regulatory requirements and project goals.
• Lead the development of risk assessments in relation to validation activities.
• Ensure validation activities are performed in accordance with SHINE validation policies, procedures, and the Master Validation Plan.
• Coordinate and help execute approved protocols for process validation, equipment installation and operational qualification (IQ/OQ), performance qualification (PQ), and requalification/revalidation of critical systems and utilities.
• Provide input and guidance on new and existing validation projects including facility systems, manufacturing equipment and processes, analytical instrumentation, and cleaning processes.
• Ensure validation initiatives adhere to specified timelines.
• Provide status and progress reports for validation/qualification activities or projects for the Management Review Meetings.
• Review FDA and EMA regulations to ensure the validation activities meet defined requirements.
• Assist in the development and preparation of protocols for process qualification, cleaning validation, equipment commissioning and qualification (including but not limited to FAT/SAT/IOQ and PQ) as well as CSV (Computer Software Validation) documentation.
• Review and analyze analytical and physical data generated from executed validation/qualification activities.
• Write validation/qualification final reports that present, summarize and offer conclusions on the validity of the processes based on objective evidence, obtain necessary approvals.
• Prepare documentation and provide support for regulatory/compliance inspections.
• Perform periodic reviews of system(s) validation and reporting for the Annual Quality Product Review.
• Work with Development, Manufacturing and Quality personnel to generate risk management deliverables for new projects, processes, and equipment.
• Reviews proposed changes for impact to system qualification and validation; identifies and completes requalification activities to support change completion.
• Collaborate closely with cross‑functional teams (R&D, Quality, Engineering, IT) to ensure alignment of validation activities with other project phases and deliverables.
• Identify opportunities for improvement in validation processes and procedures and implement corrective actions.

• BS in a scientific discipline or equivalent work experience.
• 3–5 years of experience in validation activities associated with a pharmaceutical or medical device company (preferred).
• 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 and review documentation.
• Ability to lead and motivate teams, manage projects, and communicate effectively.
• Ability to analyze data, identify risks, and develop effective solutions.
• Excellent written and verbal communication skills.

• Requires frequent leaning, bending, stooping, crouching, grasping, and reaching above the shoulders and below the knees.
• Moderate physical activity; handling average-weight objects up to 40 pounds; standing/walking more than four hours per day.
• Fine motor coordination and strong depth perception are beneficial.
• Exposure to extreme temperatures, dirt, dust, fumes, smoke, unpleasant odors, and/or loud noises.
• Some exposure to hazards or physical risks; requires following…