Senior Validation Engineer

BA/BS Degree in Chemistry, Engineering or a relevant field and 8 years of related work experience in validation/quality related discipline or drug development with emphasis in equipment qualification

OR

MA/MS Degree in Chemistry, Engineering or a relevant field and 6 years of related work experience in validation/quality related discipline or drug development with emphasis in equipment qualification

OR

PhD in Chemistry, Engineering or a relevant field and 4 years of related work experience in validation/quality related discipline or drug development with emphasis in equipment qualification

• Technical Writing
• Critical Thinking

• Provide quality review and approval of validation activities associated with changes to existing systems and projects that support the site
• Participate in protocol development and approval, investigations for deviations and champion local, corporate, and regulatory standards
• Present and support validation concepts and approaches with audits and inspections
• With limited oversight, author IQ, OQ, and PQ protocols for Quality Validation.
• Perform quality validation review and approval through the preparation, execution, data analysis for IQ, OQ and PQ protocols
• Perform quality review and approval of change requests (CR’s) related to project validation and other validation activities for the site
• Perform compliance and technical reviews/approvals of protocols and protocol data
• Review and approve validation failure investigations and non-conformities utilizing root cause analysis techniques
• Review and approve specifications, procedures, and other required supporting documents to maintain the validated state of equipment and processes and the validation
• Identify process improvements before equipment, systems or processes are placed under change control during validation
• Manage and complete each assigned annual product review (APR). This includes cooperating transversally with various departments and to ensure that data is supplied on time and is sufficient and compliant with appropriate procedures
• Communicate validation issues and requirements to plant personnel on a frequent basis through participation in engineering, R&D and management staff meetings, as well as applicable project teams
• Track all validation documentation throughout the plant and follow-up as needed
• Exhibit safety awareness and safe work practices