Responsible for Environmental operations, this includes, training and evaluating personnel; analyzing and interpreting monitoring results; and making appropriate decisions and recommendations to address trends, issues or significant observations. Demonstrates leadership in a fast-paced manufacturing setting and operates with minimal oversight and a clear understanding of business and regulatory demands. Exhibits rigorous scientific and supervisory skills, a strong practical knowledge of biopharmaceutical manufacturing environmental monitoring and testing, and excellent understanding of current Good Manufacturing Practice (cGMP), Good Laboratory Practice (GLP), Code of Federal Regulations (CFR) and/or Points to Consider (PTC) compliance requirements.
Formulates strategies for routine monitoring and microbiology testing, performance qualifications, prepares protocols and standard operating procedures (SOPs), and reviews and approves work of subordinates. Conducts, schedules, and directs monitoring and testing activities, keeping appropriate records consistent with regulatory guidance, business needs and client expectations. Gathers and collates results of environmental testing, identifies trends, interprets implications, and recommends procedural changes to drive improvement. Communicates with Management and others as appropriate. Participates in development and implementation of validation plans and protocols. Effectively assists with client and regulatory audits/inspections as appropriate
Equal Opportunity Employer Minorities/Women/Veterans/Disabled