Validation Engineer II

Validation Engineer II - Mangan, Inc. - Durham, NC .

Job Duties :

Responsible for the execution of validation projects for equipment, facilities, and utilities in a pharmaceutical manufacturing, packaging, or support environment. Coordinate execution efforts with operations, manufacturing, facilities, laboratories, development, materials management, and quality assurance personnel. Analyze validation data, prepare summary reports, and provide recommendations for improvement in manufacturing processes and equipment. Develop training packages, JSAs, and writing Best Known Methods (BKM) for Validation. Serve as a dependable liaison between validation and manufacturing. Identify, respond to, and monitor potential project risks and determine possible contingency plans for risk mitigation. Review technical and quality system documents such as SOPs, Change Control and Deviation Reports, Batch Production Records, Technical Manuals, P&IDs, construction, as-built, and flow diagrams as they relate to validation principles and regulatory compliance issues.

Minimum Requirements :

Bachelor s degree (or foreign degree equivalent) in Engineering, Science, or a related technical field. Must have 2 years of experience as a Validation Engineer, Automation Engineer, Technical Writer, or a related occupation in an Equipment Qualification in Biotechnology or Pharmaceutical GMP environment, including demonstrated experience in/with: developing Engineering Lifecycle Documents (URS, FRS, DDS, FRAs) and Validation Protocols (IQ, OQ, PQ, AIQ, VSR, PVP); change control processes in the pharmaceutical industry; 21CFR 210, 211, and Part 11; Data Integrity Requirements for Electronic Records and Signatures per 21CFR Part 11; performing validation activities for SCADA, WinCC OA, and PI tags for Building Automation Systems and Environmental Monitoring Systems; developing and executing FATs, SAT, and Startup testing for automated systems. 100% telecommuting role; may work from any location inside the U.S. - reports to company office in Durham, NC. Up to 10% travel to various unanticipated worksites within the U.S. is required. Must have legal authority to work in the

U.S. EEOE.

How to

Apply:

Send resumes to Michael Hammond, HR & Safety Director, Mangan, Inc., 3880 Kilroy Airport Way, Suite 100, Long Beach, CA 90806, or email to mhammond@manganinc.com. Please reference job title + SR26 in cover letter or email subject line.