Job Description :
Position: Laboratory Equipment Qualification Engineer Location: Summit West & Warren New Jersey Client: Mentor Technical Group Visa: USC/Green Card/ H4 EAD/TN only Laboratory Equipment Qualification Engineers Mentor Technical Group is a Minority Certified organization that provides a complete portfolio of technical support and solutions to the regulated industry. As a global leader in life sciences engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. Job Description: Develop technical knowledge of their system/area as required to develop protocols to complete commissioning and qualification of the system; including but not limited to Installation Verification, Start-up, Functional Testing, and Installation and Operational Qualification. Review and approve C&Q documents such as UR, DQ, Protocols, Master Plans, Component level Impact Classifications, IC/OC/, IQ/OQ, etc. Draft and expedite approval of their CQ protocols. Execute, summarize, and gain approval of their testing results. Work collaboratively with project support groups (e.g. automation, construction, and engineering) and the end-user representative to resolve non-conformances related to commissioning and qualification. Will manage and report on their workload and progress weekly to the project lead. Lab Equipment/systems may include GMP and nGMP equipment such as: (KFT (Coulometric), FT- NIR, LIF, NIR, Homogenizer, Spectrophotometer, DQAS, Accelerated Surface Area and Porosimetry System, KFT (Volumetric), FTIR, Titrator (Potentiometric), TPW, Freezers, Refrigerators), Disintegrator, pH Meter, Refrigerator, HPLC , GC, Dissolution Station, Dissolution Sampling System, Balance (Top Load), Head Space, KFT (Coulometric), DI Water, Glass Washer, Titrator (Potentiometric), Balance (Micro), Photostability Chamber, SFPM, Balance (Analytical), Osmometer. Requirements/Qualifications: Bachelor's degree or higher in Engineering or Sciences field. Minimum of five (5) years of experience in the qualification of laboratory equipment in a manufacturing environment is required. Experience working with laboratory systems in a laboratory environment. Experience in the qualification of laboratory equipment. Knowledge of cGMP, GXP, GAMP, and good documentation practices. Advanced knowledge of pharmaceutical, manufacturing and laboratory systems. Understanding of investigations, deviations and CAPA management in a regulated pharmaceutical industry. Strong written and verbal communication skills. Excellent interpersonal skills with experience dealing with a diverse workforce. Strong multi tasking ability in conjunction with proven organizational skills. 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. Highly proficient computer skills in Microsoft Office Suite Word, Excel, PowerPoint and Outlook with extensive background in database systems. Innate ability to learn new software, such as corporate intranet and enterprise business. Experience authoring, owning and executing qualification documentation. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.