Senior Validation Engineer

Job Responsibilities

• Work with the project team and/or General Contractor as required to support the commissioning and validation of a 60,000 sq. ft. office, warehouse, and GMP Radiopharmaceutical production facility.
• Develop and implement the CQV strategies for the GMP spaces including but not limited to office, warehouse, development, quality control, sterility/microbiology, and GMP production areas.
• Support the engineering, QC, and Operations team as required to improve and implement new processes.
• Provide validation support for day-to-day development and GMP operations.
• Expand expertise in additional areas of validation (process validation, QC assets, CSV, cleaning validation, etc).
• Own and manage a specific area of validation (i.e. process validation, QC assets, CSV, cleaning validation, etc).
• Apply technical knowledge and abilities to investigate manufacturing deviations.
• Review data and documentation to support investigations.
• Own and drive projects and continuous improvement efforts.
• Draft GMP documentation including but not limited to SOP’s, Forms, Protocols, Technical Documents, Reports, Deviations, CAPAs, Change Controls and reports.
• Support Health Authority Inspections.
• Maintain department KPIs related to performance.
• Mentor and cross-train other team members.
• Execute and provide support executing equipment and process validations as necessary.

Education And Experience

• BS or MS in scientific related field or equivalent work experience
• 4-8 years of experience in Radiopharmaceutical or injectable GMP manufacturing environment
• 4-8 years of validation experience within a GMP environment

Skills And Qualifications

• Good technical writing skill-set
• Solid understanding of regulatory guidelines for validation and risk management
• Must possess an independent mindset and tenacity
• Highly motivated and organized professional with strong interpersonal and communication skills
• Proven experience working with teams in a GMP environment
• Multi-disciplined engineer with GMP experience
• Excellent professional ethics, integrity, and ability to maintain confidential information
• Uses AI tools to enhance individual productivity and quality of work

Physical Demands

• While performing the duties of this job, the employee is regularly required to sit, reach with hands and arms, and talk or hear.
• The employee must occasionally lift and/or move up to 30 pounds.
• Specific vision abilities required by this job include close vision and distance vision.