Validation Engineer II
The Validation Engineer has a significant impact to the company engaged in the manufacture of prescription sterile gels, ointments, and solutions ophthalmic drug products. The successful candidate must have experience with aseptic practices, formulation, filling, and packaging. The successful candidate must be familiar with the current qualification/ validation practices in the pharmaceutical industry and be an adept technical writer. The position requires hands on experience with manufacturing equipment and utilities. The Validation Engineer will be a leader in the Change Control decisions and able to work with other departments to identify and solve issues that may impact the product or the validation state. The Validation Engineer will play an important role at Akorn, Inc. by working closely with all departments which may include, but are not limited to, the list below:
- Administer projects, as directed, according to Validation Master Plan
- Execute IQ/OQ for equipment and requalification
- Execute IQ/OQ/PQ for process validations
- Draft/review/approval validation protocols and reports Administer site Change Management Program Coordinate validation activities with other departments.
- Have the ability to problem solve with little oversight, including conducting research toaid in the resolution of issues that arise. Operate wireless temperature data loggers.
- Other duties as assigned
Education and Experience
Bachelor's of Science Degree in Chemistry, Engineering, Microbiology, or a related field, plus 5 years experience in the pharmaceutical industry, or equivalent experience. Demonstrated experience validating a wide range or equipment and processes (including cleaning processes), including mixing, sterile fill, parts washers, wet steam sterilization and packaging. Demonstrate experience and knowledge of qualifying changes to validated systems/processes/and equipment.
- 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.
- Previous experience in the pharmaceutical industry with a manufacturing background.
- Advanced knowledge of cGMP's and regulatory requirements as they relate to IQ/OQ/PQ/VQ's.
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.
Tue, 22 Aug 2017 08:24:16 PDT