Validation Engineer II
SUMMARY:
The Validation Engineer has a significant impact to the company. There is high criticality level for the work produced. The Validation Engineer is responsible for all respects 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 qualifications 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. site. The Validation 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 Validation 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 not limited to the list below:
ESSENTIAL FUNCTIONS:
Include the following. Other duties may be assigned.
– Schedule and plan equipment and process qualification workload to meet approved schedules.
– Handle multiple projects and work independently.
– Design and attend F.A.T. testing at vendor facility, as required.
– 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.
Requirements:
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.
– Excellent telephone and written communication skills with proven prior experience.
– Working knowledge of US regulatory submission.
– Proficient with computer programs desirable; or an aptitude to learn computer programs as needed.
– Resourceful and well organized.
– Have general math skills; adding, subtracting, multiplication, division and percentage calculation.
EDUCATION AND EXPERIENCE:
– Bachelors of Science degree in Chemistry, Engineering, microbiology, or a related fields, plus 3-5 years' experience in the pharmaceutical industry, or equivalent experience. Demonstrated experience in 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:
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.
PHYSICAL DEMANDS, MENTAL REQUIREMENTS, AND WORK ENVIRONMENT:
Requires prolonged sitting. Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator and other office equipment. Requires normal range of hearing and vision to record, prepare and communicate appropriate reports.
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 meet deadlines and effectively deal with office stress
– Ability to accurately communicate ideas, facts and technical information
– Maintain confidentiality of certain information
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.
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.
