Principal Validation Engineer

Duties and Responsibilities

• Maintain Equipment/Facility/Utilities (EFU), Computerized System (CSV) and Cleaning Validation programs in accordance with the Site Validation Master Plan and its corresponding policies and procedures
• Lead complex, high-priority validation projects that often require considerable resources and high levels of function integration
• Demonstrate skills set, knowledge and apply ASTM E2500 principles, and good engineering practices to the Site Validation Lifecycle concept
• Assure good and timely communication of validation projects status and potential issues and/or roadblocks
• Work with cross functions or stakeholders to resolve escalations or redirect the project as required
• Apply a science and risk-based approach for CQV activities to assess the need and/or extent of required validation efforts
• Collaborate with Manufacturing, Engineering, Process Support, Supply Chain, Quality and Regulatory Affairs to ensure that Commissioning Qualification Validation (CQV) project deliverables are compliant with the current regulations, current industry practices, and internal policies and procedures
• Provide leadership by training Engineering team members on validation programs and protocol life cycle
• Lead Validation Specialists to resolve technical challenges, analyze validation data and coordinate scheduling of qualifications with operational teams
• Recommend best practices towards system operation and capital planning based upon validation principles and current industry practices
• SME for Validation documents in support of regulatory and client audits
• Own Quality System elements to include SOPs, CAPAs, Change Controls, Deviations, and Investigations
• Perform Annual Product Quality Review for validation of manufacturing systems and processes
• Provide expertise in cycle development and validation of complex pharmaceutical manufacturing equipment-cleaning processes
• As applicable, perform Validation Life cycle of generation, execution, and reports for (DQ, FAT, SAT, IOPQ) of Manufacturing, QC, and Supply Chain equipment. (Cleaning, temperature mapping, sterilization)

Qualifications

• Bachelor’s Degree or equivalent in Engineering (Chemical, Chemistry, Biology, Electrical, Mechanical, etc.), Life Sciences, or related scientific discipline
• 7+ years of hands-on, direct validation experiences in pharmaceutical / biotech industries, including minimum 3 years of managing projects (CAPEX/OPEX)
• Champion to adopt / apply principles of ASTM E2500 in CDMO manufacturing operations environment
• Must have experience with cGMPs and Good Engineering Practices
• Excellent technical writing ability for technical and compliance reports or submission
• Experience in managing multiple projects and leading cross-functional project teams desired
• Detailed knowledge of disposable technology preferred

Preferred Qualifications

• Working experience with the contract development manufacturing and sterile / aseptic operations with a demonstrated knowledge of the general operation of pharmaceutical manufacturing and testing equipment
• Strong communication, prioritization, and organizational skills, attention to details