Senior Validation Engineer

Key Responsibilities

• Serve as a validation technical leader, providing subject matter expertise in qualification and validation activities across facilities, utilities, equipment, processes, and computerized systems.
• Act as key member of project teams for design, procurement and installation of new equipment and facility expansion projects.
• Establish, revise, and maintain validation project plans for qualification of equipment required for cGMP compliance.
• Own and maintain validation procedures within area(s) of subject matter expertise.
• Develop, review, approve, execute, and maintain validation lifecycle documents, including validation procedures, qualification/requalification protocols, and reports, in accordance with cGMP, GDP, and ALCOA principles.
• Maintain qualified systems in a validated state through requalification, periodic review, continued verification, change control assessments, and evaluation of validation impacts resulting from proposed changes and deviations related to validated systems and processes.
• Author and support investigation of deviations and CAPAs.
• Afford assistance with troubleshooting equipment / system failures.
• Deliver training on validation program elements to Validation Engineers.

Other Responsibilities

• Ensure that all work is performed in accordance with Standard Operating Procedures (SOPs), ALCOA principles, Current Good Manufacturing Practices (cGMP), quality standards, and safety procedures.
• Support equipment and process related non-conformance investigations and change control activities.
• Afford assistance with internal and regulatory agency audits / inspections.
• Ensure training is kept in GMP compliant state.
• Accountable for managing assigned deliverables, maintaining project milestones, and ensuring proactive, accurate communication with cross-functional teams and stakeholders.

Qualifications

• A minimum of seven years professional experience in validation, engineering, or operations.
• A minimum of seven years relevant experience in a cGMP environment is required.
• Experience with GMP utilities and equipment is required.
• Demonstrates professionalism, emotional intelligence, and the ability to build effective working relationships across functional teams.
• Strong attention to details, flexibility and technical writing skills are important for this position.
• Good knowledge of cGMP, GDP, and applicable regulatory requirements.
• Ability to work independently or in a team environment, while demonstrating initiative and accountability.