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:
- 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.
Company Overview Who we are?
- Minimum of Bachelors of Science degree in Chemistry, Engineering, Microbiology, or a related fields, plus 8 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.
- Excellent verbal 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.
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
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.