In this role, you will be the Digital Platform Senior Validation Engineer. This position is responsible for the guidance and direction of validation projects covering all the Life Science digital products, applications, and computerized systems. Your primary focus will be creating automated devices and instrumentation that facilitate chemical synthesis and sample preparation, ensuring these systems are robust, precise and scalable.
Responsibilities include but not limited to:
- Reviews regulatory requirements based on the systems need and scope of target market and internal and external use in GMP and Non-GMP areas.
- Performs 21 CFR Part 11, Annex 11, Risk Assessments, Functional risk assessments, Data Integrity Assessments, FMEA to ensure the requirements, controls are captured prior to development and ensure tested system/products met those requirements.
- Develops Test Summary Report, Traceability Matrix, Validation Summary Reports, QMS, Data Integrity White papers, IQ, OQ Protocols, FAT and management of deviation and observation.
- Leads the Operational Change Control, deviation, CAPA management, customer complaints handling, periodic review, and re-validation of multiple digital products and software applications. Actively participating as auditee presenting and explaining validation and qualification documents or reports to the regulatory, customer auditors and internal and external auditors.
Who You Are:
Minimum Qualifications:
- Bachelor's degree in Life Science (Chemistry, Biology etc) or Engineering, (Chemical, Mechanical etc) or Computer Science.
- 5+ years software or computerized validation experience.
Preferred Qualifications:
- Experience with Project Planning, Word, Excel, PowerPoint and SharePoint.
- Experience with GMPs, GCPs, GLPs, GAMP and Part 11 compliance as they relate to qualification of systems in support of validation of processes