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.
- 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.
Other duties as assigned may include:
- Drive internal communication and ensures knowledge sharing across all colleagues for operational effectiveness and consistency.
- Actively supports the business model effectively and consistently. Fully supports the efficient working environment and applies continuous improvement process.
- Bachelor’s Degree Engineering, or related scientific discipline
- In lieu of a bachelor's degree, an additional four years of experience is required in the below areas of engineering. (Next bullet)
- 5+ years of experience in areas of validation, qualification, or commissioning, preferably in the chemical, food, or pharmaceutical industries.
- Experience with the authoring and execution of documentation including validation documentation, technical protocols and/or technical reports preferred.
- Demonstrated ability for independent work that requires multi-tasking and a high level of attention to detail.
- Demonstrated ability or ability to facilitate and/or be an active participant on teams.
- Demonstrated successful communication and negotiation skills in order to manage conflicting and/or multiple demands, including ability to present to various level within an organization.
- Demonstrated knowledge of project management skills and techniques, ability to prepare timelines and schedules to ensure projects are executed on time and within budget.
- Experience working with validation and construction contractors to facilitate project deliverables.
- Knowledge of FDA Current Good Manufacturing Practices (cGMP), GAMP 5 requirements.
- Experience and Inspection interaction with FDA, EMA or other regulatory agencies preferred.
- Demonstrated proficiency in interpersonal communications, both written (technical writing required) and verbal. Demonstrated successful communication/collaborative skills, influencing skills, and negotiation skills to manage conflicting and/or multiple demands, opinions, and expectations including ability to facilitate meetings as well as present to various levels within an organization.
- Willingness to travel to external domestic and international supplier sites (typically less than 10% of the time).
- Demonstrated proficiency in computer skills as a business tool, specific work experience using Microsoft applications (Word, Excel, PowerPoint). Knowledge of application software such as Trackwise, SAP preferred.
Notification to Agencies
Please note that Hikma does not accept unsolicited resumes or calls from third-party recruiters or employment agencies. In the absence of a signed Master Service Agreement and approval from HR to submit resumes for a specific requisition, Hikma will not consider or approve payment to any third-parties for hires made.
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