Validation Engineer

The Validation Engineer will lead maintenance, engineering, and validation activities within the clinical packaging area. The scope of responsibility includes equipment, facilities, utilities, and cleaning validation. The incumbent will serve as the primary liaison with Operations, Engineering Services, and third-party vendors to coordinate and execute activities within the assigned area of responsibility.

The Validation Engineer will also be responsible for managing the area's Engineering Technician and ensuring that all activities are performed in accordance with product quality requirements, R&D standards, and Corporate Quality expectations.

• Manage all departmental capital projects and miscellaneous engineering activities, coordinating required services with internal functional support teams and external vendors.

• Manage equipment, facility, utility, and cleaning validation activities to ensure compliance with applicable quality and regulatory requirements.

• Maintain the Validation Master Plan (VMP), as appropriate.

• Prepare, manage, and maintain Validation Change Control documentation and oversee the electronic tracking system.

• Identify and implement opportunities to reduce costs, increase operational flexibility, and generate additional capacity through process improvement initiatives.

• Collaborate with Operations and Quality area managers through Validation Review Boards to support validation activities and continuous improvement initiatives.

• Ensure the integrity, quality, adequacy, and appropriateness of validation documentation through comprehensive document reviews.

• Ensure thorough investigation and timely resolution of issues related to equipment, facilities, and utilities.

• Manage validation-related quality improvement projects to ensure R&D compliance with regulatory, corporate, and departmental requirements.

• Represent the department during internal and external quality audits concerning validation and engineering compliance.

• Develop and maintain strong working relationships with Packaging Operations and Engineering and Validation teams.

• Initiate Change Requests (CRs) for Standard Operating Procedures (SOPs) supporting equipment and operational processes.

• Supervise full-time engineering technicians and contract validation engineers, as required.

• Ensure appropriate resource allocation and balanced workloads to meet forecasted business requirements.

• Partner with stakeholders across key business functions to ensure packaging equipment is properly configured and capable of supporting new and ongoing clinical studies.

• Ensure equipment reliability expectations are met in a high-throughput clinical packaging facility.

• Balance short-term production support requirements with the department's long-term strategic objectives.

• Bachelor's degree in an engineering discipline.

• Minimum of 5 years of combined work experience in validation and/or engineering roles within the pharmaceutical industry.

• Knowledge of and experience creating and executing validation documentation in a Validation Management System (VMS).

• Knowledge of and experience with client engineering and financial systems.

• General understanding of client engineering standards and specifications.

• General understanding of pharmaceutical packaging equipment.

• Pharmaceutical validation and engineering.

• Equipment, facility, utility, and cleaning validation.

• Validation Master Plan (VMP) maintenance.

• Validation Change Control documentation.

• Validation documentation creation, execution, review, and management within VMS.

• Engineering project coordination and capital project management.

• Pharmaceutical and clinical packaging equipment.

• Equipment reliability and troubleshooting.

• Quality improvement and process optimization.

• SOP change requests and change control processes.

• Regulatory compliance and corporate quality standards.

• Internal and external quality audit support.

• Engineering resource and workload management.

The ideal candidate will have a strong background in pharmaceutical validation and engineering, with experience supporting clinical packaging operations. The candidate should be capable of coordinating cross-functional teams, managing validation documentation, working with third-party vendors, supporting audits, and maintaining equipment reliability and compliance in a high-throughput packaging environment.

Candidates with local availability in or around Cincinnati, Ohio, are preferred. Relocation candidates will also be considered.

• Interview Mode: Virtual

• Submission Deadline: EOD

• Available Positions/Submission Slots: 3

Interested candidates should provide an updated resume and LinkedIn profile. References are not required.

Contract Duration: 6 months.

Work Location: Cincinnati, Ohio (Hybrid).