JOB TITLE: Sr. Validation Engineer for ERP Systems (SAP, MES, LIMS)
JOB LOCATION: Frederick, MD
JOB DUTIES: We need a great communicator to drive overall SDLC and quality performance + compliance throughout the organization by defining, implementing, and maintaining the validation program. Coordinate with end users and process owners to lead development of validation protocols - IQ, OQ and PQ protocols for ERP software such as SAP, MES, LIMS. Provide day-to-day support to team and able to lead/drive deliverables as needed. Ensure validation program meets requirements of FDA and ISO.
EDUCATION & EXPERIENCE: Minimum of a Bachelor’s degree in Engineering (E.g. Chemical Engineering, Mechanical Engineering, Biomedical Engineering) or a related field plus 6-10 years related experience.
SPECIFIC SKILLS OR OTHER REQUIREMENTS: Experience must include: Great communication skills and ability to lead. Knowledge and working application of FDA and cGMP requirements, Validation principles and guidelines and industry practice, Technical Writing including Standard Operating Procedures, Data Analysis, and Project Management knowledge. SDLC and ERP validation.