Job Function Summary: This position is responsible for managing engineering projects at all Qualitest facilities in Huntsville AL and Charlotte NC. This position also provides technical or engineering support to Qualitest Maintenance staffs in trouble shooting equipment problems. Essential Jobs:
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- Provide technical support to site maintenance staff on all utility systems including: Electrical Distribution, Chilled Water, Steam Systems, Boilers, HVAC, Purified Water System, Domestic Hot and Cold Water Systems and Clean Compressed Air Systems.
- Manage the following activities associated with major facility and utility upgrade projects: o Preliminary engineering and cost estimates o Development project scope and capital expenditure approval documents. o Engineering and construction bid packages by formal request for proposal process for projects over $100K. Smaller projects by obtaining multiple quotes. o Ensure that detailed engineering documentation (i.e drawings and specifications) are prepared in accordance with all applicable codes and regulations and meets customer requirements. o Manage construction and engineering activities. o Manage project budgets and timelines o Ensure commissioning and start-up testing is performed. o Ensure turnover documentation is obtained of all testing and installation activities.
- Manage activities related to equipment engineering: o Develop User Requirement Specifications (URS) o Selection and specification of new equipment (i.e. Functional and/or design specifications (FRS, DS)) o Procurement of new equipment o Performance of equipment factory/site acceptance testing. o Technical direction to manufacturing in regards equipment operation. o Assuring change controls are completed for equipment upgrades and non-like for like part changes. o Perform commissioning for new equipment and upgrades to critical utility systems and cGMP facilities and provide input to and support the execution of the Equipment Qualifications.
- Support manufacturing in the operation and maintenance of critical and non-critical utility systems that support manufacturing. Other jobs:
- Other duties as assigned by the Director of Engineering. Experience and Education:
- Minimum of 5 years of engineering and maintenance experience preferably in a pharmaceutical environment.
- Bachelors of Science degree in an engineering discipline.
- Fluent in the use of computer software such as Microsoft word and Excel and AutoCad. Physical Requirements:
- Able to wear a respirator
- Able to stand on concrete surface for 2-3 hours at a time
- Able to climb stairwells and ladders
- Able to lift 25 pounds