WuXi AppTec

  • Manager - Environmental Monitoring

    Job Locations US-PA-Philadelphia
    Job ID
    2018-3477
  • Overview

    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

    Responsibilities

    • Manages, plans and reviews operations for assigned staff, including responsibility for training, managing and evaluating as well as coordinating, scheduling and assigning work and maintaining facility's standards.
    • Initiates, prepares and revises new protocols, SOPs, Deviations, Investigations and other technical documents as directed by management.
    • Interacts with pertinent internal departments (e.g. Manufacturing and Quality Control) to assure that appropriate testing information is effectively communicated.
    • Demonstrates leadership and support of company goals and objectives.
    • Responsible for gathering, collating, interpreting and reporting environmental testing results, and for making sound recommendations based on the results.
    • Demonstrates independent scientific technical expertise and programmatic leadership.
    • Conducts critical review of test results and reports data to appropriate internal staff.
    • Reports observations of ongoing tests to appropriate internal staff.
    • Effectively interacts with clients and/or regulators to address scientific and related issues.
    • Interacts with subcontractors (as appropriate) and assumes responsibility to ensure timely and accurate completion of all subcontracted work.
    • Maintains full compliance for areas of responsibility with GLP, cGMP, CFR and/or PTC guidelines and SOPs.
    • Maintains accurate records and other required documentation according to and in compliance with GLP, cGMP, CFR and/or PTC guidelines and SOPs. 

    Qualifications

    • Bachelor of Science in Microbiology or similar field
    • 5 or more years of experience required
    • Knowledge and experience in sampling and testing air (e.g., settling plates, RCS), water, surfaces (contact plates, swab samples), solutions, chemicals, materials, and personnel microbial contamination.
    • Knowledge of monitoring and testing manufacturing utilities, including air (e.g., Met-One particle counter), water (sampling for USP tests) and clean steam for quality and non-biological contaminants.
    • Knowledge of sampling and testing to support studies of cleaning and sterilization efficiency.
    • Ability to direct both biological and non-biological testing of environmental samples, and to critically assess and communicate the implications of the testing results.
    • Sufficient breadth and experience to appropriately interpret testing results, making sound recommendations and decisions.
    • Knowledge of cGMP guidelines is required.
    • Ability to make decisions based on a wide knowledge of factors where application of advanced or technical concepts is predominantly required.
    • Ability to evaluate technical data and write technical documents.
    • Ability to use judgment as dictated by complexity of situation.
    • Ability to work under limited supervision and to handle problems of a difficult nature.
    • Ability to accomplish the described duties through the use of appropriate equipment and software.
    • Ability to accurately and reproducibly perform arithmetic calculations including fractions, decimals and percentages and basic algebraic and geometric calculations.
    • Ability to record data accurately and legibly.
    • Ability to understand and follow verbal or demonstrated instructions

    Equal Opportunity Employer Minorities/Women/Veterans/Disabled

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