Mangan, Inc

Role Description 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. Qualifications - 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. - 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. Requirements - 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. 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.