Validation Engineer I

Job ID 19-00039

Industry Pharma

Job Type Permanent

Location Decatur, IL


The Validation Engineer has a significant impact to the company. There is a high criticality level for the work produced. The Project Engineer is responsible for all aspects of the validation process, including: documenting commissioning activities, establishing the process and equipment acceptance criteria, and developing and performing qualification studies to document evidence which provides a high degree of assurance that equipment and processes (including cleaning processes) will consistently produce a product meeting its predetermined specifications and quality attributes. The Project Engineer will play an important role at Company, Inc. by working closely with all departments and by being responsible for various projects, which may include, but are not limited to, the list below:
Essential Functions:
Schedule and plan equipment and process qualification workload to meet approved schedules.
Handle multiple projects and work independently.
Write, execute, and review complex protocols.
Coordinate validation activities with other departments.
Operate Thermal Mapping Equipment
Have the ability to problem solve with little oversight, including conducting research to aid in the resolution of issues that arise.
Train other Validation personnel.
Purchase supplies and equipment for validation activities.
Administer the site Change Control Program.


Ideal Candidate:
Bachelors of Science Degree in Chemistry, Engineering, Microbiology, or a related field required. 3+ years' experience in the pharmaceutical industry, or equivalent experience required. Demonstrated experience validating a wide range of equipment and processes (including cleaning processes), including mixing, sterile fill, freeze drying, parts washers, vial washers, depyrogenation, wet steam and dry heat sterilization and packaging. Demonstrated experience and knowledge of qualifying changes to validated systems/processes/and equipment.