Sr. Engineer, Equipment Validation

Job Title: Sr. Engineer, Equipment Validation

Location: Columbus, OH

Job Type: Full-Time

Req ID:7108

 

About Us:

As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates’ mission is to bring Better Health. Within Reach. Every Day.® for millions of patients around the world.  We are a trusted, reliable partner and dependable source of over 750 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe.  Through our 32 manufacturing plants, eight R&D centers, and 8,500+ employees worldwide, we are always hard at work creating high-quality medicines and making them accessible to the people who need them.

 

Description:

We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds.  We are seeking a talented and motivated T Sr. Engineer, Equipment Validation to join our team. 

In this role, you will be directly responsible for the management and execution of all validation activities related to production and/or facility equipment though a range of project sizes and complexities.

Provide project support and guidance on small and large scale validation/qualification initiatives to internal project teams to ensure project deliverables are met. Ensure equipment systems are in compliance with regulatory requirements through maintaining change control process and conducting periodic reviews. Investigate / make sound recommendations for validation compliance concerns or new regulations and support regulatory inspections by taking an active role in the process

 

Key Responsibilities:

Serve as project manager for validation/qualification aspects of complex projects in targeted areas that could be multi-faceted (potentially >$1M). Lead development of validation strategy to ensure regulatory guidelines are followed relative to the equipment validation topic. Identify and procure contract validation services when required, including development of requests for proposals, proposal/contract review, coordination of approvals, and interface with contract service personnel in the oversight of the validation activities to make certain resources are available to meet validation project deliverables. Direct task assignment, schedule development, evaluation of procedure adherence, and proper documentation archival.

Author validation plans and oversee the development of specifications (user requirements, functional requirements, and design requirements), trace matrices, validation summary reports and test protocols for installation, operation, and performance under the guidance of the department manager or designee. Provide direction on Equipment Change Control development in accordance with appropriate procedures.

Lead the maintenance of assigned system validation state by developing, approving, and monitoring proper testing as part of the change control program. Perform or oversee periodic reviews of systems to monitor the validation status of systems and execute necessary actions to close gaps discovered through the process. This includes review and analysis of change controls, review of equipment documentation, and review of other equipment procedures and processes.

Take a leadership role in the development and modification of Standard Operating Procedures (SOPs), Work Instructions (WIs) and guidelines for equipment validation policies, standards, procedures, and templates (including test cases). Investigate and identify industry trends in validation and expectations of regulatory agencies and modify the program as appropriate to align with current requirements. May provide regional or global support on procedures, best practices, or continuous improvement projects related to equipment validation.

Develop and coordinate ongoing guidance and training of site personnel on policies and procedures related to equipment validation, including requirements, best practices, and lessons learned. Mentor and train colleagues on policies and procedures, including the requirements for validation.

 

Qualifications

• Bachelor’s Deg