Validation Technician l

Organization
Akorn, Inc.
Job Location
Somerset, NJ
Job Description

SUMMARY:
The Validation Technician is responsible for establishing documented evidence which provides a high degree of assurance that equipment and processes will consistently produce a product meeting its predetermined specification and quality attributes. The Validation Technician will play an important role at Akorn, Inc,. by working closely with all departments. Under limited supervision and guidance of the Validation Manager and/or Director, the Validation Tech I is responsible for various duties, activities and projects, which may include, but are not limited to, the list below.
ESSENTIAL FUNCTIONS:
- Execute validation protocols.
- Review protocols.
- Create, maintain, inventory, safeguard and update validation records.
- Coordinate validation activities and work closely with, but not limited to, Microbiology, Chemistry, Maintenance, and Manufacturing departments.
- Operate data logging system(s) (Ellab TrackSense) for qualifications of steam processes (sterilizers and Steam-In-Place (SIP)) and temperature controlled units (stability chambers, incubators, refrigerators, freezers, ovens).
- Review and analyze validation data and write summary reports.
- Regular re-evaluation and continual optimization of protocols, qualifications and validation activities.



Requirements: 

ADDITIONAL RESPONSIBILITIES:
- Planning, design, and implementation of validation projects, protocols, and SOPs.
- Purchase supplies and equipment for validation activities.
- Special projects as assigned.
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.
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.

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