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KBI Biopharma
KBI Biopharma

60 Kbi Biopharma Validation Engineer Jobs Hiring Near You

KBI Biopharma, Inc.

Senior Engineer, MS&T

Boulder, CO · On-site

$118K - $178K/yr

In-depth knowledge of process validation practices and associated regulatory expectations ... If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any ...

KBI Biopharma, Inc.

Senior Engineer, MS&T

Boulder, CO · On-site

$118K - $178K/yr

In-depth knowledge of process validation practices and associated regulatory expectations ... If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any ...

KBI Biopharma, Inc.

Senior Engineer, MS&T

Boulder, CO · On-site

$118 - $178/hr

In-depth knowledge of process validation practices and associated regulatory expectations ... I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If ...

KBI Biopharma, Inc.

QA Specialist II

Durham, NC · On-site

Responsible for the review and approval of method qualifications and validations * Responsible for ... KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore ...

KBI Biopharma, Inc.

QA Specialist II

Durham, NC · On-site

Responsible for the review and approval of method qualifications and validations * Responsible for ... KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore ...

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KBI Biopharma Jobs Information

Does KBI Biopharma pay people when they’re sick?

Yes. Most people get paid when they’re sick.
100% of people say they would get paid if they were sick but scheduled to work.
Based on data from 6 people who took the Breakroom Quiz between December 2024 and September 2026.

At KBI Biopharma, are sick days and vacation days separate paid time off?

Sick days and vacation days are separate paid time off.
80% of people say they don’t have to use vacation days when they’re out sick.
Based on data from 5 people who took the Breakroom Quiz between May 2025 and June 2026.

Is the health insurance from KBI Biopharma affordable enough for their workers?

Most people say the health insurance costs are okay.
100% of people say the health insurance costs are okay
Based on data from 6 people who took the Breakroom Quiz between May 2025 and September 2026.

Do people get paid time off at KBI Biopharma?

Most people get paid time off work.
83% of people say they get paid time off.
Based on data from 6 people who took the Breakroom Quiz between May 2025 and September 2026.

Do workers at KBI Biopharma worry about hours?

Most people don’t worry about getting enough hours.
100% of people report they don’t worry about getting enough hours.
Based on data from 6 people who took the Breakroom Quiz between December 2024 and September 2026.

How easy is it to get time off at KBI Biopharma?

Some people find it hard to get time off.
67% of people report it’s hard to get time off.
Based on data from 6 people who took the Breakroom Quiz between December 2024 and September 2026.

Do KBI Biopharma managers change schedules at the last minute?

Most managers don’t change people’s schedules at the last minute.
83% of people say their manager doesn’t change their shift schedule at the last minute.
Based on data from 6 people who took the Breakroom Quiz between December 2024 and September 2026.

Do jobs at KBI Biopharma spill into time workers aren’t paid for?

Rarely. The job doesn't usually spill into unpaid time.
33% of people report that their job takes up time that they don’t get paid for.
Based on data from 6 people who took the Breakroom Quiz between December 2024 and September 2026.

How easy is it to take sick days at KBI Biopharma?

Some people find it hard to take sick days.
43% of people report that it’s hard to take time off if they are sick.
Based on data from 7 people who took the Breakroom Quiz between December 2024 and September 2026.

Do people at KBI Biopharma feel treated with respect by their managers?

Most people feel treated with respect by their managers.
100% of people say they’re treated with respect by their managers.
Based on data from 6 people who took the Breakroom Quiz between December 2024 and September 2026.

Do people at KBI Biopharma get to take their breaks without interruption?

Only some people get breaks without interruption.
67% of people report that their breaks get interrupted.
Based on data from 6 people who took the Breakroom Quiz between December 2024 and September 2026.

Is it stressful to work at KBI Biopharma?

Most people feel stressed here.
71% of people say they often feel stressed at work.
Based on data from 7 people who took the Breakroom Quiz between December 2024 and September 2026.

Do people at KBI Biopharma enjoy their jobs?

Most people enjoy their job.
80% of people report they enjoy their job.
Based on data from 5 people who took the Breakroom Quiz between December 2024 and March 2026.

Do people at KBI Biopharma recommend working with their team?

Only some people recommend working with their team.
43% of people report that they wouldn’t recommend working with their immediate team to a friend.
Based on data from 7 people who took the Breakroom Quiz between December 2024 and September 2026.

Do people get enough training when they start at KBI Biopharma?

Most people didn’t get enough training when they started.
71% of people report they didn’t get enough training when they started working here.
Based on data from 7 people who took the Breakroom Quiz between December 2024 and September 2026.

Do people get support to advance at KBI Biopharma?

Most people are given support to advance their career here.
In the last year, 67% of people report being given support to advance their career here.
Based on data from 6 people who took the Breakroom Quiz between December 2024 and September 2026.

Do people think KBI Biopharma’s headquarters understands what’s happening where they work?

Most people think headquarters doesn’t understand what’s happening where they work.
100% of people think that this employer’s headquarters or owners don’t have a good understanding of what’s really happening where they work.
Based on data from 7 people who took the Breakroom Quiz between December 2024 and September 2026.

Do workers feel well informed about how KBI Biopharma is doing?

Only some people feel well informed about how the company is doing.
67% of people feel that they aren’t kept well informed about how the company is doing as a whole.
Based on data from 6 people who took the Breakroom Quiz between December 2024 and September 2026.

What other companies are hiring for Validation Engineer jobs?

What are the most popular jobs at Kbi Biopharma?

What are the most popular categories at Kbi Biopharma?

Infographic showing various Validation Engineer job openings at Kbi Biopharma in the United States as of August 2026, with employment types broken down into 100% Full Time. Highlights an 94% Physical, and 6% Remote job distribution.

Sr/Principal Computer Systems Validation Specialist

KBI Biopharma, Inc.

Durham, NC • On-site

$133K - $183K/yr

Full-time

Medical, Dental, Vision, Retirement, PTO

Re-posted 26 days ago

Key responsibilities

  • Provide oversight, review, and approval of validation lifecycle deliverables for enterprise software projects.

  • Manage validation review and approval of change controls, CAPAs, and deviations related to enterprise software.

  • Support global data integrity initiatives and contribute to the development of policies, SOPs, and templates for IT enterprise software.

KBI Biopharma rating

6.3

Company rating: 6.3 out of 10

Based on 7 frontline employees who took The Breakroom Quiz

Job description

This individual will provide thought-leadership, expertise, and management of managed validation services to the IT Validation & Compliance infrastructure in a Contract Development and Manufacturing Organization (CDMO) setting. Individual will be responsible for the validation review and approval of enterprise software validation lifecycle deliverables and the validation technical oversite of change controls,CAPAs, and deviations associated with enterprise software. Working closely with partners in Quality Validation, this individual provides strategic and technicalexpertise for all global software validation related matters, including assurance thatall aspects comply with cGMPs, legal, regulatory requirements, and the KBI internal requirements.

Job Responsibilities:

  • Provide oversight of enterprise software validation from a global perspective.

  • Provide validation direction, guidance, review, and approval for validation lifecycle deliverables of enterprise software projects.

  • Provide oversight and management to validation managed services for associated projects

  • Provide validation review and approval of enterprise software change controls, CAPAs, and deviations.

  • Provide support for data integrity global initiatives.

  • Provide expertise and input for global Policies, SOPs, and Templates for IT Enterprise Software

This position will be based in Durham, NC and will require a regular site presence.

Minimum Requirements:

  • (Principal - BS/MS and 15+ years/ Senior - BS/MS and 8+ years) experience in a cGMP environment in a computer systems validation role with demonstrated career growth and accomplishments.

  • Experience in Data Integrity, computer system validation/IT quality in an FDA regulated manufacturing environment. Demonstrated expert knowledge of 21CFR, Part 11, and/or EU Annex 11 as well as current regulatory guidance on Data Integrity.

Salary Range:

$118,000 - $162,800 (Senior)

$133,000 - $183,700 (Principal)

Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate's qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, Sabbatical program, 401K matching with 100% vesting in 60 days and employee recognition programs.

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.

I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.

I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.

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