Validation Technician

Want to Expand

your career-development potential,

your ability to help donors and patients,

and your access to professional opportunities?

We’re growing fast.

[You can, too!]

There are so many ways Octapharma Plasma can enhance your life and your career. Our strong growth is creating great learning and career development opportunities throughout our company, and especially our donation centers. Because you’re someone who loves to learn, enjoys people, and has a real heart to help, we encourage you to join us as a: Validation Technician

This is What You’ll Do

• Develops and maintains equipment validation policy and adheres to regulatory requirements.
• Performs the development and execution of process validation protocols and documents consistent with FDA and EU guidelines.
• Ensures regulatory requirements are met during development and execution of equipment validation protocols.
• Develops, executes, and maintains validation protocols for donor center, laboratory, and plasma storage warehouse equipment - including freezers, refrigerators, Anti-D refrigerators, and supply room temperature mapping - ensuring alignment with cGMP, GAMP, and good engineering practices.
• Develop protocols for temperature studies (e.g., plasma thawing, volume changes, collection process modifications)
• Analyzes resulting data to ensure product quality and compliance with regulatory standards.
• Reviews, approves, and summarizes executed validation protocols, investigates deviations, and ensures timely resolution of nonconformities.
• Maintains strict adherence to the organization’s SOPs, FDA and EU regulations, and state/local laws governing equipment validation and plasma storage quality.
• Performs other duties as assigned.

This is What it Takes

• Three (3) years’ experience biologics, drug manufacturing, or medical device industry or FDA regulated laboratory.
• One (1) year of validation or relatable experience in regulated industry.
• Prior use of use of equipment: calibrated, temperature monitoring, data loggers, etc. preferred
• Ability to travel up to 40%.

Physical Requirements

• Position works at donation centers fleetwide
• Ability to view video display terminal images 18” away from face for extended periods of time
• Ability to sit for extended periods of time
• Ability to use a computer and other office equipment
• Ability to occasionally lift and carry up to 20 pounds
• Ability to reach, bend, and stoop as necessary
• Ability to communicate effectively, both verbally and in writing
• Ability to focus and concentrate on tasks for extended periods
• Ability to navigate the office environment safely, including stairs and elevators (if applicable)
• Ability to travel up to via airplane or vehicle
• Ability to use assistive devices if needed for mobility or communication
• Ability to work in temperature-controlled environments, including temperatures as low as -40C

Do Satisfying Work. Earn Real Rewards and Benefits

We’re widely known and respected for our benefits and for leadership that is supportive and hands-on. Managers who truly want you to grow and excel.

• Formal training
• Outstanding plans for medical, dental, and vision insurance
• Health savings account (HSA)
• Flexible spending account (FSA)
• Tuition Reimbursement
• Employee assistance program (EAP)
• Wellness program
• 401k retirement plan
• Paid time off
• Company paid holidays
• Personal time

With donation centers and team members throughout the U.S., Octapharma Plasma, Inc. collects plasma to create life-saving medicines for patients worldwide. We are growing at an impressive pace, and so is the positive impact of our work. Our community relies on teamwork, compassion, and expertise to get things done the right way, while making a meaningful difference in the lives we touch.

Interested? Learn more online and apply now at:

octapharmaplasma.com

And if you know someone else who'd be a great fit at Octapharma Plasma, Inc. please forward this post