Software Validation Associate

Would you like to develop your skills working for a mission-driven organization while playing an important role in leading the way in Life Sciences? AlloSource is a BioTech company headquartered in Centennial, Colorado. 

Here at AlloSource we’re not looking for jobseekers. We want people dedicated to our mission of restoring hope to donor families and helping patients heal through our innovative cellular and tissue allografts.  This takes a special person with a strong desire to help make a tremendous impact on people’s lives. Regardless of which department you work in at AlloSource, we value your efforts, your top-notch skills, and your abilities to contribute to our ultimate goal of saving or enhancing human life!  What better reward is there than knowing you contributed, in some way, to save or enhance a person’s life!   If this sounds like an organization you wish to be a part of, then we invite you to apply

Summary: 

The Software Validation Associate is responsible for leading software validation activities necessary to meet company-wide validation requirements and ensure compliance to regulations. These activities include but are not limited to: requirements specification creation, validation protocol development and execution, software testing, trace matrix and FMEA creation, deviation resolution and reports.

Anticipated Application Deadline:   December 22, 2025 

Pay: $ 72,419/yr   -  $88,583/yr based upon years of relevant experience  

Shift:    Monday-Friday; 8:00am to 5:00pm; hybrid work schedule, working three days in the office, two days from home

Benefits: Medical, Dental, Vision, Life Insurance.    Click link for more benefits details: View the 2026 Employee Benefits Summary    

Location:    6278 S Troy Circle Centennial, Colorado 80111 

Essential Duties and Responsibilities:   

• Works closely with the software system owners to develop requirements and manage the validation project all with all cross functional resources.
• Develop and implement manual test scripts that support validation qualifications.
• Participate in Failure Investigations, Nonconformance Reports, Corrective/Preventative Actions.
• Exercise good quality and regulatory judgment when executing daily job duties.
• Educate end user on the need-to-know aspects of software validation.
• Label creation, update and adjustment in compliance with regulations for medical device, tissue and biologic products.
• Adhere to and promote proper practices and techniques which are consistent with current operating procedures, training requirements, safety practices and company policies.
• May perform other related duties and responsibilities as assigned.

Requirements:  

• Bachelor’s degree 
• In lieu of degree, 7 years of quality compliance within a regulated medical industry may be substituted, in addition to demonstrated technical aptitude within software validation. 
• 3-5 years authoring and executing software validation documents OR 5-8 years’ experience working with quality records in an FDA regulated industry, with 5 years working with a specified QMS.  This experience must be combined with 5 years technical writing experience. 
• 3 years quality compliance within a regulated medical industry.  
• Working knowledge of 
  • 21 CFR Part 11 
  • Risk Based Approach to Software Quality & Validation 
  • Spreadsheet Validation 
  • ISO standard for labelling of medical devices    
• Proficiency in Microsoft Office Application 

• Ability to communicate in English proficiently (speaking, reading, writing, and comprehension)
  
  

Preferred Experience:  

• Fundamentals of 21 CFR Part 11 
• Risk Based Approach to Software Quality & Validation
• Spreadsheet Validation
• ISO standard for labelling of medical devices 
• 4 years executing validation documents
• Report writing or similar technical work
• Experience with FDA or other regulated audits; including customer audits 
• Regulated work environment

It is the policy of AlloSource not to discriminate against qualified individuals with disabilities in regard to application procedures, hiring, advancement, discharge, compensation, training or other terms, conditions and privileges of employment. If you need reasonable accommodation to apply for a position, please contact us at 720-873-0213.  

For consideration, you must apply online, submit a current resume and meet the minimum requirements.  Candidates within a 50-mile radius of the hiring zip code may receive first consideration. 

Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, pregnancy, genetic information, disability, status as a protected veteran, or any other protected category under applicable federal, state, and local laws.

AlloSource uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit www.dhs.gov/E-Verify.