Lubrizol Environmental Monitoring Supervisor in Bethlehem, Pennsylvania
Environmental Monitoring Supervisor
Particle Sciences, A Lubrizol Company is the leading CDMO for complex formulation development for the pharmaceutical industry, with over 20 years of successful experience and a solid base of clients ranging from the world’s largest pharmaceutical and biotech companies to small VC backed start-ups. As a member of the Particle Sciences, Inc. team, you will be working for a company that is engaged in important, exciting, and socially relevant projects. Particle Sciences is a fast-paced environment that features a variety of projects, technical challenges, and opportunities for growth. To learn more about Particle Sciences, A Lubrizol Company, visit www.particlesciences.com and https://www.lubrizol.com/Life-Sciences .
The Environmental Monitoring Supervisor will be responsible for oversight of the EM program to support current Good Manufacturing Practice (cGMP) manufacturing. Experience with quality aspects for manufacture of sterile products is preferred. The applicant will be required to become aseptic certified and to enter in aseptic manufacturing areas for support of activities.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Responsibilities include, but are not limited to:
Environmental Monitoring Supervisor will have supervisory responsibility of the EM group.
Responsible for all Environmental Monitoring procedures and reports and ensuring compliance to current global regulatory standards.
Ensure all Environmental Monitoring processes are performed in accordance to company policies.
Oversee the environmental monitoring program including generation of documentation such as risk assessments and trending reports.
Coordinate the Environmental Monitoring schedules of pharmaceutical cleanrooms and associated spaces on a daily basis according to cGMP and company requirements.
Responsible for coordinating environmental monitoring activities with third party vendors.
Provide technical guidance to operations and other support areas regarding EM and sterility assurance matters.
Provide technical support for EM initiatives involving viable, non-viable and personnel monitoring. Manage procedural revisions if needed.
Lead and provide documentation for root cause investigations of EM excursions.
EDUCATION AND PREVIOUS EXPERIENCE:
Must have Bachelor’s degree, preferably in a scientific field, with 5+ years’ experience in pharmaceutical industry, or equivalent combination of education and experience with knowledge of current Good Manufacturing Practices (cGMP). Degree in microbiology is a plus.
Previous experience in environmental monitoring and/or support of pharmaceutical manufacturing, especially for sterile products, is a must.
Must have strong oral and written communication skills, and effective interpersonal skills.
Experience with leading investigations and root cause analysis is a plus.
Particle Sciences’ headquarters is located in Bethlehem, PA, part of the Lehigh Valley region of Pennsylvania. Lehigh Valley includes the cities of Allentown at http://www.visitpa.com/cities/allentown , Bethlehem at http://www.visitpa.com/cities/bethlehem and Easton at http://www.visitpa.com/cities/easton . The region is slightly over an hour to both Philadelphia and New York City, which places you right in the action. Buzzing with business, culture, knowledge and entertainment, the Lehigh Valley is a vibrant place for people of all ages and walks of life to live, learn, work and play. This region offers a little bit of everything for everyone - ethnically-diverse communities, affordable housing, award-winning schools and universities, world-class healthcare, ski resorts, museums, casinos, shopping, restaurants, sports and nightlife. From the yearly Musikfest at http://www.musikfest.org/ festival, to skiing in the Poconos at https://www.poconomountains.com/ , to hiking or biking through the many state parks, you can make it happen right here in the Lehigh Valley at http://www.visitpa.com/regions/lehigh-valley .
Lubrizol is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to sex, race, color, national origin, citizenship, age, religion, marital status, military service, sexual orientation, genetic information, gender identity, or any other characteristic or trait protected by federal, state, or local law.
Nearest Major Market: Allentown
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