Job Description
Duties and Responsibilities:
Currently supervises Physical Monitoring technicians. Responsibilities include employee work performance evaluations, discipline and training.
Evaluate new Physical Monitoring employee prospects for hire.
Schedules and designs work of direct report personnel.
Administrator of the Kaye Temperature/Humidity Monitoring system and the Facility Pressure Monitoring System. Responsible for system and software upgrades.
Project leader for all critical facility qualification efforts (ie., coordination of support services and implementation of qualification testing, report generation). Researches the data pertaining to the newly built or renovated area and prepares detailed validation test protocols. Listed below are additional duties relative to the project leader responsibility:
Prepares validation test protocols.
Performs validation testing.
Prepares/Reviews validation reports.
Serves as team coordinator for the Process Validation/Engineering Project review committee and the Process Validation Department project review meetings.
Manages numerous critical testing programs. Listed below are the testing programs which are actively managed:
Manages the HEPA filter testing program.
Manages the non-viable particulate monitoring program.
Manages the Nitrogen gas line monitoring program.
Manages the Clean Steam monitoring program
Active participant in the Environmental Action Committee. Environmental Active Committee responsible to assess impact of environmental occurrences on product. Responsible for data reviews and research to help resolve Environmental Actions which occur.
Reviews/Approves Standard Operating Procedures.
Performs short and long term planning relating to departmental and company needs.
Performs other duties as assigned or directed to aid in meeting global objectives of the Process Validation Department.
Requirements:
Requires a four year degree in a science or engineering related discipline. Must demonstrate general knowledge of scientific principals and reasoning, which become crucial to problem solving systems failures or environmental anomalies.
Requires a minimum of one year experience working with environmental monitoring systems (i.e. temperature, pressure, humidity, etc) and a working knowledge of HVAC systems (preferably pharmaceutical). In addition a moderate knowledge of computer systems and softwares is highly recommended (ie., LAN/mainframe functioning, pc configurations, database usage, and word processing/software in the Windows environment.)
Requires a minimum of one year supervisory experience; responsible for the training, supervision and discipline of direct report personnel.
Requires initiative and ingenuity as duties are typically complex technically where decisions are made to determine appropriate course of action; usually does not receive direction on any type of regular basis.
Requires good interpersonal skills in order to maintain good working relationships within the department, BVL organization and outside the organization (ie, customers).
Requires good communicative skills in order to obtain or present technical data to associates within the organization or with customers.
Requires intense review and critique skills in that, undetected errors regarding Media fill qualifications might cause moderately serious delays, confusion, or expense to correct.
Position frequently requires close concentration, in order to meet deadlines or handle emergencies.
Requires physical activity such as moderate sitting, standing, walking, eyestrain, etc.
Works regularly under desirable conditions with come moderately disagreeable conditions within the manufacturing facility.
Requires engineering expertise in order to assist the Engineering Department with evaluating installation and operational specifications of automated HVAC control systems.
Provides engineering expertise to the Engineering Department related to major facility upgrades: Evaluates GMP impact of proposed facility upgrades; Evaluates environmental impact of proposed facility upgrades; Provides guidelines/specifications to the Engineering Department for establishing design criteria.
Provides Engineering Department with troubleshooting assistance concerning automated HVAC control systems.
Coordinates emergency meetings relative to facility shutdown issues. Ensures all departments are made aware of their test responsibilities and test timelines.