Engineer, Equipment Validation

About the role

We are seeking a talented and motivated Equipment Validation Engineer to join our team. In this role, you will be responsible for authoring validation documentation and the management and execution of all validation activities related to production and/or facility equipment.

Responsibilities

• Provides project support and guidance on validation/qualification initiatives to internal project teams to ensure project deliverables are met.
• Ensures equipment systems are in compliance with regulatory requirements through maintaining change control process and conducting periodic reviews.
• Author validation plans and coordinate 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.
• Support the maintenance of assigned system validation by developing, approving, and monitoring proper testing as part of the change control process.
• 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.
• Participate in the development and modification of Standard Operating Procedures (SOPs), Work Instructions (WIs) and guidelines for validation policies, standards, procedures, and templates (including test cases).
• Support ongoing guidance and training of site personnel on policies and procedures related to equipment validation, including requirements, best practices, and lessons learned. Collaborate with higher level engineers on development of training materials.
• Support the business model effectively and consistently. Fully supports the efficient working environment and applies continuous improvement process.
• Serve as project coordinator or project manager for validation/qualification aspects of projects, either independently or under the guidance of department manager/designee depending on project complexity.
• Support development of validation strategy to ensure regulatory guidelines are followed relative to the Equipment Validation topic. Support task assignment, schedule development, evaluation of procedure adherence, and proper documentation archival.
• Drive internal communication and ensure knowledge sharing for operational effectiveness and consistency.
• Direct contract resources as required to ensure execution of validation scope.

Qualifications

• High School Diploma (or equivalent) and 4+ years of GMP Pharma experience.
• Bachelor’s Degree in Engineering or related scientific discipline.
• 0–2+ years of experience in areas of validation, qualification, and/or commissioning, preferably in the chemical, food, or pharmaceutical industries.
• Demonstrated ability for independent work that requires multi-tasking and a high level of attention to detail.
• Ability to facilitate and/or be an active participant on teams.
• Demonstrated successful communication and negotiation skills to manage conflicting and/or multiple demands, including the ability to present to various role levels within the organization.
• Ability to occasionally travel (globally) for equipment FATs (Factory Acceptance Testing) (10%).

Preferred Qualifications

• Experience with the authoring and execution of validation documentation, technical protocols, and/or technical reports.