Job Summary The Pharma Validation Facility Engineer is responsible for leading maintenance, engineering, and validation activities within the clinical packaging area, including equipment, facilities, utilities, and cleaning validation. This role serves as the primary liaison between packaging operations, engineering services, Quality, and external vendors to ensure equipment reliability, regulatory compliance, and product quality. The position oversees capital projects, validation documentation, change control, continuous improvement initiatives, and engineering technician resources to support clinical packaging operations in accordance with R&D, corporate quality, and regulatory requirements.
Roles and Responsibilities- Lead and manage departmental capital projects, engineering activities, and technical support initiatives in coordination with internal teams and external vendors.
- Manage equipment, facility, utility, and cleaning validation activities to ensure compliance with applicable regulatory and corporate quality standards.
- Develop, maintain, and update the Validation Master Plan (VMP) and oversee validation change control documentation and electronic tracking systems.
- Prepare, review, execute, and approve validation documentation to ensure accuracy, completeness, integrity, and compliance with established requirements.
- Identify and implement process improvement initiatives to reduce costs, improve operational flexibility, increase capacity, and enhance equipment performance.
- Collaborate with Operations, Quality, Engineering Services, and other functional teams through Validation Review Boards to support compliant and efficient operations.
- Investigate and resolve equipment, facility, and utility issues in a timely manner while ensuring minimal disruption to clinical packaging activities.
- Lead validation-related quality improvement projects to maintain compliance with regulatory, corporate, and departmental requirements.
- Represent the department during internal and external quality audits, providing documentation and technical support related to validation and engineering compliance.
- Establish and maintain strong working relationships with packaging operations, engineering, validation teams, and third-party service providers.
- Initiate and manage change requests for Standard Operating Procedures (SOPs) supporting equipment operation, maintenance, and process changes.
- Supervise engineering technicians and coordinate contract validation engineering resources, ensuring appropriate workload distribution and resource utilization.
- Ensure packaging equipment meets functional, reliability, and performance requirements to support new and ongoing clinical studies.
- Balance immediate production supports requirements with long-term engineering strategies, lifecycle equipment management, and continuous improvement objectives.
- Coordinate engineering and validation activities to maintain product quality, operational readiness, and compliance with applicable pharmaceutical standards.
Education and Experience- Bachelor's degree in engineering or a related engineering discipline is required.
- Minimum of 5 years of combined experience in pharmaceutical validation, engineering, maintenance, or related technical roles within the pharmaceutical industry.
- Hands-on experience preparing, reviewing, and executing validation documentation using a Validation Management System (VMS).
- Knowledge of equipment qualification, facility and utility validation, cleaning validation, and change control processes.
- Experience developing and maintaining Validation Master Plans (VMPs) and supporting validation lifecycle activities.
- Working knowledge of pharmaceutical packaging equipment, equipment reliability, and clinical packaging operations.