Akorn 2 Validation Engineer I - 1006BR in Decatur, Illinois

This job was posted by https://illinoisjoblink.illinois.gov : For more information, please see: https://illinoisjoblink.illinois.gov/ada/r/jobs/6211453 SUMMARY:nnThe 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, 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 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:nnESSENTIAL FUNCTIONS:nnnSchedule and plan equipment and process qualification workload to meet approved schedules.nHandle multiple projects and work independently.nWrite, execute, and review complex protocols.nCoordinate validation activities with other departments.nOperate Thermal Mapping EquipmentnHave the ability to problem solve with little oversight, including conducting research to aid in the resolution of issues that arise. nTrain other Validation personnel.nPurchase supplies and equipment for validation activities.nAdminister the site Change Control Program.n

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nQualificationsn

QUALIFICATIONS:nnTo 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.nnEDUCATION AND EXPERIENCE:nnBachelors 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.nnJOB PREREQUISITES:nnnAbility 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.nPrevious experience in the pharmaceutical industry with a manufacturing background.nAdvanced knowledge of cGMP's and regulatory requirements as they relate to IQ/OQ/PQ/VQ's.nnPHYSICAL DEMANDS AND WORK ENVIRONMENT:nThe 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.nnMental Requirements include:nnnAbility to hear accurately the spoken word with moderate office noise or plant noisenAbility to apply deductive reasoning and understand complicated issuesnAbility to receive instructions and follow work rules and company policiesnAbility to follow safety and security practicesnAbility to occasionally work off hours and wee ends to meet deadlines.nAbility to effectively deal with office stressnAbility to accurately communicate ideas, facts and technical informationnAbility to maintain confidentiality of certain informationn

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nCompany Overviewn

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, 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.

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nEEO Statementn

Akorn, Inc. is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.