West point, PA, 19486, USA
1 day ago
Deviation Management Specialist
Job Title: Deviation Management Specialist Location: West Point, PA - Hybrid Hours/Schedule: M-F 8am-5pm Pay Range: $35 - $41.75/hr Type: Contract, Potential for extension or conversion to permanent Responsibilities + Primary responsibilities include day-to-day technical support to manufacturing operations, including resolution and reduction of process deviations, development and implementation of corrective/preventative actions, and leading manufacturing investigations + This individual will be responsible for providing scientific support for manufacturing areas within company's Manufacturing Division + This Individual will also develop working relationships with counterparts in other areas supporting aseptic manufacturing, testing, planning, and release and is required to utilize sound scientific and engineering principles to investigate process deviations + Troubleshooting and root cause analysis of laboratory test failures and manufacturing atypical events, development of corrective/preventative actions is required + Analysis of complex problems through critical analytical thinking + Off-shift work may be required Requirements + B.S./M.S. degree in appropriate engineering/scientific field + Minimum of 0-3+ years post-Bachelors degree experience in a cGMP environment (e.g. Production, Development, Process Engineering, Technical Services or related field) in pharmaceutical/ biotech industry + Previous experience in writing investigations for atypical events in a manufacturing environment + Familiar with Lean Six Sigma Methodologies and proven analytical/ problem solving capabilities + Demonstrated ability of meeting goals/timelines/organizational skills + Excellent written and verbal communication skills + Demonstrated ability to work both independently and as a part of a cross-functional team + Preferable skills-Environmental monitoring experience, Formulation and filling experience, Line manufacturing experience (project engineer, maintenance and facility engineer, Experience in Bulk/Drug substance Manufacturing). Benefits System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan. Ref: #558-Scientific System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan. System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
Confirmar seu email: Enviar Email