How to Maximize
your opportunity to do rewarding work,
your future leadership potential,
and your career growth?

Join an Industry Leader[Become one, too!]

Octapharma Plasma offers professional opportunities that make a meaningful difference. We enhance the lives of patients who need our life-saving medicines. We reward the donors who provide the plasma we collect to make them. And we inspire growth and development in the teams at our donation centers, offices, and labs. We invite you to do the same in this role:

Validation Analyst II

This Is What You’ll Do:

• Develops and maintains equipment validation policy and adheres to regulatory
• Performs the development and execution of process validation protocols and documents consistent with FDA and EU
• Ensure regulatory requirements are met during development of equipment validation
• Develops equipment validation protocols and documents consistent with good engineering practices and current Good Manufacturing Practices (cGMP).
• Develops and maintains donor center freezer, refrigerator, and Anti-D refrigerator validation protocols to be executed
• Develops and maintains donor center supply room temperature mapping protocols to be executed
• Develops and maintains laboratory freezer and refrigerator validation
• Develops and maintains plasma storage warehouse freezer and processing area validation
• Develops protocols for temperature studies to include, but not limited to: lasma case and unit thaw, changes in collection volumes, changes in plasma bottle size, changes in plasma collection process
• Analyzes and interprets validation and study data to determine if requirements are
• Reviews and approves executed equipment validation testing
• Develops equipment validation summaries to support executed protocol and address deviations found during execution.
• Works with third party equipment and software vendors to ensure processes developed to perform maintenance or implementation meet cGMP and OPI quality
• Exports configurations and maintains current and archived NexSys PCS software and configurations files for the donor center

This Is Who You Are:

• Excellent interpersonal skills, strong written and verbal communication skills.
• Highly ambitious and ability to think outside of the box.
• Eager to share new ideas and contribute to a team.
• Self-motivated and willing to assume the initiative.
• Attentive to every detail.
• Capable of thriving while working independently.

This Is What It Takes:

• Bachelor’s degree in IT, life science or related field
• Three years’ experience biologics, drug manufacturing, or medical device industry or FDA regulated laboratory
• Minimum of two (2) years of validation experience in regulated industry
• Minimum of two (2) years of software validation experience
• Demonstrated knowledge of cGMPs, FDA regulations, SOP implementation, and validation principles and compliance
• Completion of GAMP
• Demonstrated excellent interpersonal, written, and verbal communication
• Demonstrated ability to work
• Demonstrated experience working with all levels in an
• Normal amount of travel is expected and may be up to 15%. Requirements may increase depending on business

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.

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

More About Octapharma Plasma, Inc.

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.

INNER SATISFACTION.

OUTSTANDING IMPACT.