Validation Engineer II
Akorn 2

SUMMARY:

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:

ESSENTIAL FUNCTIONS:
Include the following. Other duties may be assigned.

• Handle multiple projects and work independently.
• Write, execute, and review complex protocols.
• Coordinate validation activities with other departments.
• 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.
• Operate wireless temperature data loggers
• Administer the site Change Control Program.

Qualifications
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 a minimum of 5 years’ experience in the pharmaceutical industry. 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.

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.
• 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.

PHYSICAL DEMANDS, MENTAL REQUIREMENTS, 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

Company Overview
Who we are?

Aside from being a pharmaceutical industry leader with deep roots in the eye care community, Akorn has proven through the years, to be a company of clear vision. A vision of what it takes to continually develop and evolve in order sustain our mission, which is to improve patients’ lives through the quality, availability and affordability of our products. Along with developing and manufacturing branded and generic ophthalmics, Akorn manufactures injectable, oral liquid, optic, topical, inhalant, and animal health products. To learn more please visit our website at www.Akorn.com .

Why choose us?

Akorn employees are modern day superheroes! That might sound like an exaggeration; however, when you think of it, superheroes help those in need. That is exactly what we do here at Akorn. If you choose to work with us, you are not choosing to work an ordinary job. You are choosing to make an impact in this world. You are choosing to have a career with purpose. If you are seeking a rewarding opportunity where you can make a difference for others, then put on your cape and join the team!!

What do we offer?

• Competitive pay
• Growth and development opportunities
• Tuition Reimbursement
• 3 weeks PTO + Personal Days
• 9 company holidays
• 401K match
• Medical, Dental and Vision Benefit Options
• 100% Paid Maternity Leave
• Fast paced, family-oriented work environment
• Wellness Program
• Inclusive and diverse culture
• Adoption Assistance
• Flexible Spending Accounts

EEO Statement
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.

This job has expired.