Job Description

PRINCIPAL DUTIES:

1. Provides Engineering Department with troubleshooting assistance concerning automated HVAC control systems.

2. Coordinates emergency meetings between Engineering, Facility Maintenance, Production, Quality Assurance, Sanitation, and Environmental Control relative to facility shutdown issues. Ensures all departments are made aware of their test responsibilities and test timelines.

3. Obtains, organizes, and reviews raw environmental data obtained in post maintenance qualification and assesses potential impact to the facility in such events as floods, power outages, etc.

4. Complete quarterly trending of environmental monitoring performed by the Physical Monitoring Group including temperature, humidity, and pressure for management and customer review.

5. Assist in the execution of routine Validation qualifications including freeze drier audits, hot air oven audits, etc by programming KAYE temperature monitoring devices, mapping qualification loads, etc.

6. Develop protocols for container closure validations and manufacturing process validations. Coordinate events between Validation, Environmental Control, and Production to ensure proper execution of validation protocol.

7. Obtain, organize, review, and assess raw environmental data and batch records obtained in the execution of the protocol in the form of a Validation report.

8. May occasionally show other employees how to perform tasks within the scope of knowledge and as instructed by the immediate supervisor.



KNOWLEDGE, SKILLS & EXPERIENCE:



1. Requires a 2-3 associate degree in a science-related area of study or two years of college-level coursework with a science concentration.

2. Requires 2-3 years experience as a Physical Monitoring Technician in pharmaceutical industry. Experience working with environmental monitoring systems (i.e. temperature, pressure, humidity, etc.) and a working knowledge of HVAC systems (preferably pharmaceutical) is required.

3. Must be able to demonstrate general knowledge of scientific principals and reasoning.

4. A moderate knowledge of computer systems and software (i.e., LAN/mainframe functioning, PC configurations, database usage, and word processing/software in the Windows environment) is highly desirable.

5. Must meet and maintain all requirements to work in the clean room environment.

Benefits

Dental, Holidays, Life, Medical, Vacation, Vision

Contact Details

Name: Alliance Staffing Solutions