Validation Engineer

Job Responsibilities:

• Promote and maintain a safe, compliant, and high-quality work environment through adherence to established safety procedures, policies, and industry standards.
• Ensure compliance with applicable domestic and international regulatory requirements and quality guidelines related to pharmaceutical manufacturing and validation activities.
• Monitor project timelines and communicate progress toward deliverables and milestones.
• Support cleaning validation activities, including visual inspection processes and sampling techniques for manufacturing systems and equipment.
• Assist with the execution and documentation of validation lifecycle activities for equipment, utilities, facilities, and computerized systems within regulated manufacturing environments. Activities may include risk assessments, commissioning support, qualification protocols, performance verification, and periodic reviews.
• Coordinate validation-related project activities, including scheduling, resource planning, risk management, and collaboration with cross-functional teams such as Operations, Engineering, Quality, and Technical Services.
• Review and analyze validation data, prepare technical reports, and support deviation or exception investigations when necessary.
• Utilize industry-standard temperature mapping and monitoring systems during qualification activities.
• Develop, review, and maintain controlled documentation including SOPs, change controls, validation protocols, and reports.
• Maintain awareness of current regulatory expectations and industry best practices related to validation and cGMP operations.
• Provide guidance and support for training and development initiatives within validation and quality functions.
• Participate in SOP revisions and continuous improvement initiatives to maintain alignment with operational and regulatory requirements.
• Support investigations, root cause analysis activities, and implementation of corrective and preventive actions (CAPAs).
• Assist during internal and external audits by supporting validation documentation reviews and addressing observations or compliance concerns.
• Travel periodically to support validation and qualification activities across multiple operational sites.

Qualifications:

• Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline preferred; equivalent experience may be considered.
• Several years of experience in validation, quality, or pharmaceutical manufacturing environments preferred.
• Experience supporting sterile or aseptic manufacturing processes is highly desirable.
• Familiarity with validation lifecycle methodologies, cGMP regulations, and pharmaceutical production operations.
• Understanding of manufacturing equipment, utilities, and packaging systems within regulated industries.
• Strong organizational, analytical, and problem-solving skills with the ability to manage priorities in a fast-paced environment.