EM Supervisor

Piramal Enterprises - Lexington, KY

Full-time - Mid Level

Lexington, KY

Securities, Commodity Contracts, and Other Financial Investments and Related Activities

About the position

The Environmental Monitoring Supervisor serves to supervise the environmental monitoring program and staff to support manufacturing, meet project timelines, and ensure compliance with cGMP standards.

Responsibilities

• Effectively mentors and supervises the night or day shift Cleanroom Services team, including all activities associated with environmental monitoring such as: Viable and Non-Viable Particulate Monitoring, Surface Monitoring, Microbial Identification, Purified Water, Water for Injection, and Clean Steam Systems.
• With Microbiology Manager oversight, prepare, review, approve and deploy Processes, SOPs, EVRs & CAPAs, EM Trend Reports, metrics, and etc. to provide a robust and controlled sterility assurance program.
• Provides and/or manages cGMP and safety training to the Microbiology Technicians.
• Provides information regarding Quality Control systems and data to internal or external regulatory personnel during inspections or inquiries as required.
• Develop and implement procedural guidelines for Cleanroom Services in conjunction with Quality Assurance.
• Ensure that equipment and instruments are qualified for their intended use.
• Under managerial supervision, establish and implement Policies, SOPs, and good record keeping practices.
• Troubleshoot equipment and communicate with FEQ and vendors to ensure calibration and functional equipment is in use.
• Train EM Techs in environmental monitoring tasks and standard microbiological procedures.
• Manage and ensure that smooth function of the manufacturing support team, including organizing the frequency of testing and prioritizing work load on a daily basis.
• Analyze and trend results and perform statistical evaluations of key performance indicators.
• Regularly monitor applicable internet and written information published by US FDA, pharmaceutical manufacturing and laboratory technology organizations for the purpose of review/incorporation of latest requirements and guidelines into routine operations.
• Support the transfer and optimization of microbiological methods, equipment and technology related to EM, aseptic technique, media fills, and sterility assurance.
• Provide support, if necessary, to the technical team in sampling, testing, microbial identification and laboratory housekeeping/cleaning.
• Ensure Sustained Permanent Inspection Readiness (PIR)

Requirements

• 3+ years of applied Microbiology experience in a commercial pharmaceutical, GMP manufacturing environment (preferably parenteral and in a CMO/CDMO/Clinical Environment).
• Prior supervisory experience in a laboratory environment is preferred

Nice-to-haves

• Possess excellent technical writing and oral communication skills.
• Working knowledge as it relates to Micro Lab Operations, EM, SAL and the following pharmaceutical Industry guidelines, standards, and statutes: ISPE (International Society of Professional Engineers) guidelines, FDA and PDA Parenteral Drug Association guidelines, cGMP pharmaceutical industry standards for cleaning, sterilization, and environmental monitoring and control, US Code of Federal Regulations, Titles 210 and 211, US Pharmacopoeia methods and general information chapters related to sterility assurance
• Knowledge and understanding of cGMPs; Knowledge of cGMP validation requirements and techniques
• Knowledge and experience in cGMP CA/PA, root-cause analysis, risk assessment and investigation tools and techniques
• Experience managing direct reports
• Proficiency using Microsoft Office applications