Job TitleBS degree in Engineering, Biology, Chemistry, Computer Science, or equivalent. 7 years of combined experience in FDA-regulated GMP lab environment. Must have experience validating and using common lab equipment and stand-alone computerized lab systems. Must have experience qualifying manufacturing facilities, utilities, common equipment, temperature-controlled chambers, and GMP storage areas. Must have experience and strong working knowledge of initiating, routing, implementing, and closing change controls, investigations, and CAPA using quality management systems software, such as eQRMS, TrackWise, or equivalent. Must have experience and strong working knowledge of initiating, routing, editing, reviewing, and approving controlled documents using enterprise content management platforms, such as Documentum, VeevaVault, or equivalent. Strong knowledge of cGXP requirements and good documentation practices relating to computerized systems, equipment, and instrumentation within the pharmaceutical industry. Advanced knowledge of 21 CFR Part 11 compliance and Data Integrity requirements. Strong knowledge and experience with the operation and qualification of pharmaceutical laboratory, facilities, utilities, and manufacturing systems. Strong experience writing and executing system validation & equipment qualification documents. Ability to interact effectively with laboratory personnel, QA, and Facilities groups. Maintains a high level of multi-tasking ability in conjunction with proven organizational skills. Strong ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion. Ability to effectively manage multiple tasks and activities simultaneously. Strong written and excellent verbal communication skills along with excellent leadership skills that encourages empowerment and ownership within the team and organization. Extremely proficient at writing well-formulated emails and reports. Ability to follow oral and written instructions, read and interpret engineering manuals/drawings relevant to the assigned task. Ability to effectively communicate with employees, contractors and vendors. Strong experience with technical writing and document development / generation. Innate ability to learn new software as required for equipment qualification and system validations. Expertise in the evaluation of new computerized systems in an effort to identify compliance gaps early on in the process and implement mitigations to ensure the highest quality standards are met.
