Come join our team and work in our new, state-of-the-art facility located in Florham Park, NJ. The Operator, Microbiology is responsible for supporting Tech Ops microbiology testing for release of clinical and commercial products and environmental monitoring. This includes the ability to interface with multiple groups, the ability to independently perform tasks, interpret results, and troubleshoot. Additionally, when needed, this position will be able to assist with training and microbiology assay development/implementation.
Perform daily, laboratory release sampling of cGMP environments, routine laboratory monitoring, and product release testing. Operate in classified manufacturing environments and cleanroom suites. Work cohesively with cross-functional teams in support of operational efficiency, flexibility, and assurance of timely completion of testing.
Learn and understand principles of aseptic gowning, including the use of scrub suits, cover gowns, and/or Tyvek suite in various clinical manufacturing laboratories. Ability to gown appropriately for cleanroom/GMP manufacturing is required with passing rounds of gowning qualifications to obtain clearance into the cGMP laboratories.
Ability to adhere to Good Documentation Practices. Execution and daily completion of multiple environmental monitoring records and entry of data into electronic databases. Consistently perform various laboratory duties and aseptically test time sensitive material with accuracy and precision.
Execute SOPs/protocols to support Quality Control Operations. As needed, provide daily technical updates to management. Provide input during team review of technical documents, such as SOPs.
Concentrate with great attention to details, good focus, and ability to perform repetitive technical tasks. Ability to accurately and completely understand, follow, and apply cGMP requirements with on-the-job training.
Familiarity with various microbiology and environmental monitoring techniques and equipment through education and/or industry experience. Ability to assist with Technical writing and data trending.
Problem solving ability/mentality, technically adept, and logical with strong organization skills.
Capacity to communicate effectively with peers, department management, and cross-function peers to ensure all timelines are met.
Demonstrate initiative, courage, and continuous improvement throughout investigation/corrective action lifecycles.
Education and Experience
Minimum Qualifications (Must have)
BS degree in Biology or related scientific discipline, ideally a microbiology background. An equivalent combination of education and experience may substitute.
Strong organizational and time management skills
Ability to work well in a team environment
Excellent verbal and written communication skills as well as strong focus and attention to detail.
Ability to perform frequent physical tasks with strength and mobility. Daily tasks call for routine walking and standing in cleanroom environments and occasional lifting of heavy materials.
Flexible scheduling required
Minimum of 1+ years of relevant experience with Environmental Monitoring within cGMP environments.
Understanding of federal regulations for Quality Systems (21CFR820) and GMP manufacturing (21CFR 210,211) including Gowning Qualifications
Demonstrated scientific creativity, technical proficiency, and knowledge of scientific concepts
Understanding of clinical cGMP manufacturing operations and related gowning
Knowledge of GxP regulations (cGTP, cGDP, cGMP)
Independent and self-starting.
Eager and adaptable
Position primarily operates for extended periods of time in classified cleanroom environments. Daily gowning in company provided scrubs, PPE and clean room attire.
Fast paced, start-up environment which may periodically require work beyond standard business hours.
Must be able to lift and transport at least 25 pounds on a daily routine basis
Handling of potentially biohazardous material (human cells, tissues, etc.).