Project Engineer I, Validation

Our Company
Akorn, Inc. is a niche pharmaceutical company that develops, manufactures and markets generic and branded prescription pharmaceuticals as well as animal and consumer health products. We specialize in difficult-to-manufacture sterile and non-sterile dosage forms including: ophthalmics, injectables, oral liquids, otics, topicals, inhalants, and nasal sprays. Akorn markets its products to retail pharmacies, ophthalmologists, optometrists, physicians, veterinarians, hospitals, clinics, wholesalers, distributors, group purchasing organizations, and government agencies.

Summary
The Project 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, coordinating F.A.T. and S.A.T. testing, 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 be a leader in the Change Control Process by understanding validated systems/processes/equipment and how changes will impact the validated status. The Project Engineer will play an important role at Akorn, 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
1. Schedule and plan equipment and process qualification workload to meet approved schedules.
2. Handle multiple projects and work independently.
3. Design and attend F.A.T. testing at vendor facility, as required.
4. Write, execute, and review complex protocols.
5. Coordinate validation activities with other departments.
6. Operate Thermal Mapping Equipment
7. Have the ability to problem solve with little oversight, including conducting research to aid in the resolution of issues that arise.
8. Train other Validation personnel.
9. Purchase supplies and equipment for validation activities.
10. Administer the site Change Control Program.

Qualifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education and Experience
Bachelor's of Science Degree in Chemistry, Engineering, Microbiology, or a related field, plus 3 years experience in the pharmaceutical industry, or equivalent experience. 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. Demonstrate experience and knowledge of qualifying changes to validated systems/processes/and equipment.

Job Prerequisites
1. Ability to meet attendance standards. All full-time employees are required to work a 40-hr week. At times it may be necessary to work additional hours in order to get the required tasks accomplished to meet deadlines.
2. Previous experience in the pharmaceutical industry with a manufacturing background.
3. Advanced knowledge of cGMP's and regulatory requirements as they relate to IQ/OQ/PQ/VQ's.

Physical Demands, Mental Requirement, and Work Environment
The noise level is usually fairly quiet. Requires normal range of hearing and vision to record, prepare and communicate appropriate reports. Requires exposure to machines and occasionally chemicals and solvents. Requires moving of loaded carts into and out of equipment. Preparing loads of different weights and sizes to use for validation purposes.

Mental Requirements include:
Ability to hear accurately the spoken word with moderate office noise or plant noise
Ability to apply deductive reasoning and understand complicated issues
Ability to receive instructions and follow work rules and company policies
Ability to follow safety and security practices
Ability to occasionally work off hours and weekends to meet deadlines.
Ability to effectively deal with office stress
Ability to accurately communicate ideas, facts and technical information
Ability to maintain confidentiality of certain information


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