Senior Validation Engineer

Job Responsibilities:

• You will have engineering validation oversight and engineering validation signatory responsibility for approval of commissioning, qualification/validation, and final report documents
• You will be responsible for assessing, qualifying, and validating equipment, critical systems (utilities), facilities, computer systems, and cleaning, as applicable (IQ/OQ/PQ/PV)
• Primary tasks include the development of protocols, coordination of validation activities, qualification/validation execution, preparing final reports, and assembly of final validation
• Work with Document Control function to maintain adequate records such as systems and equipment drawings, specifications, protocols, schedules, validation records and reports, etc., as required to establish control of all processes, systems and equipment.
• Final documents are archived and may be included in or support regulatory submissions, and made available during internal and external regulatory/compliance audits
• Apply thoughtful understanding of GMP, relevant SOP curriculum, routine project procedures, project management, and other training
• Generate and review Change Control documents, site validation documents, and site Standard Operating Procedures.
• Lead and interface with team members (Engineering, Manufacturing, Regulatory Affairs, Quality Operations, Quality Validation, Supply Chain, and other technical disciplines) representing the respective validation elements
• Emphasis is on ensuring accuracy and integrity on validation documentation meets regulatory guidelines and industry standards
• Write protocols and reports, execute validation documents regarding acceptability to industry standards (GMPs, FDA Guidelines), procedures, and regulatory requirements
• Utilize Quality-Engineering tools to problem solve/troubleshoot and assist in risk analysis (e.g., FMEA, traceability matrices, Design of Experiments, QbD, SPC)
• Use validation test equipment to support validation activities

Qualifications:

• Bachelor's degree or equivalent in Biomedical, Mechanical, or Manufacturing Engineering
• 5+ years of experience of Validation activities for Pharmaceutical manufacturing
• Working cross-functionally with Production, Engineering, and QC departments