Description

INCOG BioPharma is seeking a highly motivated Principal Validation Engineer with commissioning and qualification of sterile manufacturing systems, combination packaging, or automation, computer system, and software assurance expertise to join our team. The Principal Validation Engineer is a key individual contributor role within the INCOG BioPharma Validation Department. The Principal Validation Engineer is responsible for understanding and implementing validation requirements for a sterile injectables manufacturing facility. The ideal candidate has subject matter expertise and practical experience in serialization, automation, and computerized systems following risk-based approaches.

The Principal Validation Engineer will partner with internal customers to meet the needs of client projects, facility upgrades, capital expansion projects, and laboratory systems. They will possess a demonstrated ability to influence positive outcomes without direct reporting authority. Additionally, they must thoroughly understand and be able to adapt to the changing needs of a manufacturing environment.

Essential Job Functions:
• Own validation lifecycle planning for assigned projects such as laboratory instruments and systems, serialization, and computerized systems such as ERP, QMS, CMMS, MES, etc.
• Serve as the main point of contact and technical lead for client validation support and technical guidance.
• Provide validation expertise and oversight for capital expansion projects/build outs.
• Perform process gap assessments and identify continuous improvement opportunities to raise departmental standards.
• Work directly with the Technical Writers as the SME to develop and modify Standard Operating Procedures (SOPs), Work Instructions (WIs) and guidelines for validation policies, standards, procedures, and templates.
• Perform change management impact assessments and set the standard for required validation activities.
• Assess risks involved in processing steps related to systems, developing and/or reviewing validation requirements and design deliverables.
• Identify industry trends in validation and expectations of regulatory agencies and propose program modifications as appropriate to align with current requirements and guidance.
• Mentor and train validation engineers on validation philosophy, strategy, and execution.
• Represent validation during client audits and regulatory inspections as a subject matter expert.

Special Job Requirements:
• Bachelor's degree or higher in a STEM discipline
• 10+ Years of experience in Validation or related discipline
• 4+ Years GMP experience required
• Physically capable of working onsite

Additional Preferences:
• Master's degree or higher preferred
• 5+ Years CSV/CQV experience preferred
• Strong working knowledge of risk-based approaches to CQV of sterile manufacturing equipment and/or CSV/CSA