OriGen Biomedical™ is a growing, privately-held medical device manufacturer founded in 1997 and headquartered in Austin, Texas. We are a leading producer of cryopreservation, cell culture, and respiratory products. Our focus is to produce a range of products to support the treatment of respiratory distress, cancer, genetic conditions, and other life-threatening diseases. Our products are proudly designed with the patient and user in mind and we strive to maintain excellent customer service to ensure that patient care is always the top priority. The primary way to achieve this goal is to hire the right people that share our vision.

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Current Job Openings

How to Apply: Interested candidates should send their resume, title(s) of job for which they wish to be considered, and salary requirements to hr@origenbio.com. Unfortunately, due to the volume of candidates, it is not possible to follow up with all applicants, but we invite you to visit OriGen’s Career Page often, as we are updating with new opportunities frequently.  We look forward to hearing from you.

IT Engineer

Position Summary

The IT Engineer is responsible for maintaining and upgrading computer hardware and software systems.

Essential Duties and Responsibilities

The essential duties and responsibilities of this position include, but are not limited to the following:

  • Provides User support on hardware and software
  • Does Network repairs, upgrades and troubleshooting
  • Technical writing
  • Work in a highly regulated industry
  • Administration and support of Salesforce platform and Epicor ERP system
  • Administration and maintenance of Windows Active Directory and SQL Server
  • Creation and support of reports in SQL Server Reporting Services
  • Provides support for site security policies and processes, including but not limited to developing policies for successful implementation across the business (both physical and cyber-security)

Competencies

  • Experience with SQL databases
  • Good interpersonal skills

Minimum Qualifications (Knowledge, Skills, and Abilities)

  • Bachelor’s degree in Computer Science/Math/Engineering
  • Ability to understand and interpret customer needs; ability to work with all departments (i.e. Regulatory, Operations, Human Resources, Engineering)
  • Ability to work independently and lead in a team environment

Preferred Qualifications

  • Experience with Epicor ERP software suite
  • Experience with Salesforce/BarTender/SQL Server

Supervisory Responsibility

This position has no direct supervision. The individual may also be required to lead project teams and ensure participants meet deadlines.

Work Environment

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

This job often operates in a cleanroom environment. Cleanroom environment requires personnel to wear personal clothing completely covering the legs; company-provided cleanroom coat, bouffant, face mask, and gloves.

Physical Demands and Work Environment

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential job duties and responsibilities of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.

While performing the duties of this position, the employee is regularly required to talk and hear. The employee is frequently required to use hands, fingers, handle or feel objects, tools, or controls. The employee is occasionally required to stand; walk; sit; and reach with hands and arms. The employee must occasionally lift and/or move up to 60 pounds. Specific vision abilities required by this position include close vision, distance vision, color vision, and the ability to adjust focus. The noise level in the office environment is usually minimal but there may be increased noise or fumes in the warehouse and/or shipping and receiving areas.

Salary:

Commensurate with Experience

QA Engineering Manager

Position Summary

The QA Engineering Manager is responsible for all quality system and product quality activities for OriGen Biomedical, including ensuring compliance to global quality system regulations and standards such as 21 CFR 820, ISO 13485:2016 and MDSAP. This position oversees the quality team and manages the daily activities associated with releasing high quality products under a compliant quality management system.

Essential Duties and Responsibilities

The essential duties and responsibilities of this position include, but are not limited to the following:

  • Leads a team of quality personnel, including specialists, and engineers, acting as a mentor and facilitating effective communication and workload/priority management
  • Ensure effectiveness of the quality management system, including planning, managing and executing quality policies, procedures, and programs
  • Ensure compliance of the quality management system with global regulations and standards
  • Provides advice and knowledge in regard to interpreting cGMP/QSR guidelines and regulations
  • Evaluate the performance of the production process and quality of resulting products to improve existing methods of operation
  • Identify and guide areas of QMS improvement and enhancement to meet both the needs of the organization and any new or changing regulatory requirements
  • Coordinate internal and external quality system audits, including those from regulatory authorities, notified bodies, and customers
  • Manage the complaint and CAPA processes, including efficient resolution of complaints and implementation of appropriate corrective and preventive actions to correct or prevent deficiencies
  • Carry out vendor qualification and act as primary contact for customers wanting to qualify OriGen as a vendor
  • Manage document and change control procedures, as well as the training program to ensure all employees maintain training to pertinent procedures
  • Proactively looks for opportunities to identify change, increase efficiency, influence decisions and deliver results while ensuring compliance
  • Develops, modifies, and drives towards meeting quality metrics that successfully measure the output and adequacy of the quality system
  • Reports progress, issues, challenges, and opportunities to the Director of RA/QA, gathering input, feedback and support as needed to achieve quality goals

Supervisory responsibility

  • Supervises department of 3 and growing
  • Develops and optimizes department schedules
  • Maintains training of current QA staff
  • Recruits and trains new QA personnel
  • Works closely with other supervisory personnel

Competencies

  • Building Relationships: proven leadership, including ability to motivate, teach/mentor and delegate
  • Teamwork – build a team and be a member of the team
  • Demonstrated interpersonal skills, including ability to work cross-functionally to achieve business goals
  • Conflict Resolution
  • Effective communication skills (verbal and written)
  • Performance management
  • Sound critical thinking, problem solving and independent decision making
  • Adaptability/ flexibility – open to others thoughts/ideas
  • Self-awareness – ability to give and receive feedback and regulate emotions
  • Strong organization and time management skills
  • Proactive and self-starter

Minimum Qualifications (Knowledge, Skills, and Abilities)

  • Bachelor’s degree in Science, or equivalent
  • 6 years professional work experience Quality Assurance
  • 2 years direct supervisory/ leadership experience
  • Quality Systems knowledge in a regulated environment, including subject matter expert knowledge in 21 CFR 820 and ISO 13485:2016

Preferred Qualifications

  • Experience with both quality system and quality engineering/ product quality
  • Experience and sound knowledge in MDSAP requirements and audits
  • Experience working in a manufacturing environment with ISO-qualified cleanrooms

Physical Demands and Work Environment

The physical demands described here are representative of those that must be met by any employee to successfully perform the essential job duties and responsibilities of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.

While performing the duties of this position, the employee is regularly required to talk and hear. The employee is frequently required to use hands, fingers, handle or feel objects, tools, or controls. The employee is occasionally required to stand; walk; sit; and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, color vision, and the ability to adjust focus. The noise level in the work environment is usually moderate.

Cleanroom Tech for Medical Device Production - Morning and Evening Shift

Morning Shift: Work hours: five days, 8 hour shifts (Monday-Friday 5:45am – 2:15pm).

Evening Shift: Work hours: four days, 10 hour shifts (Monday-Thursday  2:15pm – 12:45am). 

The Clean Room Tech (CRT) is responsible for: assembly, testing, and packaging of medical devices and components. Required to understand and comply with drawings, written procedures, batch records and apply these standards to their work.

Essential Duties and Responsibilities

The essential duties and responsibilities of this position include, but are not limited to the following:

  • Ability to meet production schedules and deadlines according to quality standards
  • Ability to work in a flexible and changing environment
  • Ability to follow detailed written and verbal instructions
  • Ability to learn multiple tasks and train in other areas as needed
  • Ability to work with a variety of tools and equipment
  • Ability to maintain all logs, paperwork, and forms accurately
  • Required to understand, access, and make entries to documents on the company Electronic Document System
  • Ability to accurately perform job duties with minimum supervision
  • Ability to adhere to cleanroom dress code and policies
  • Ability to work in a multi-cultural team environment and be a team player
  • Ability to work in a cleanroom environment for extended periods of time
  • Punctual and Reliable!!

Required Skill Sets

  • Must be detailed oriented and be able to focus on a repetitive task for long periods of time
  • Must be proficient on a computer, possessing basic navigation and program knowledge
  • Must be able to absorb, assimilate and accurately recall/locate and retain large quantities of data/information
  • Must be able to read, write, speak and fully understand English

Competencies

  • Adaptability/Flexibility
  • Ethical Conduct/Integrity
  • Communication/Listening
  • Detail-Oriented
  • Interpersonal skills
  • Personal Effectiveness
  • Teamwork

Minimum Qualifications (Knowledge, Skills, and Abilities)

  • Basic computer navigation and program knowledge
  • Strong organization and time management skills with the demonstrated ability to meet deadlines
  • Pays very close attention to detail
  • Ability to work independently and within a team environment  

Preferred Qualifications

  • Prior Clean Room experience preferred

Compensation

Based on experience and ability

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Why Work at OriGen Biomedical

Are you looking for a job that excites and inspires you while making a difference in people’s lives?

Working at OriGen means you are directly making an impact on patient lives. Our products are used in the treatment of various conditions and life-threatening diseases. You’ll enjoy a positive, stimulating, and inclusive environment – with opportunities to grow, all while making a difference.

Our Full-Time Benefits

The physical, mental, and financial health of our employees and their families is a top priority for OriGen. This is why we have a strong, competitive benefits program, which includes:

  • Competitive pay with possibilities of bonuses and merit-based raises
  • Health, vision, and dental insurance plans available
  • Base level health insurance is free to the employee with a $500 contribution to your Health Savings Account by OriGen
  • Employer-paid long-term disability and life insurance up to 1 year of employee’s annual salary
  • 401(k) Retirement Savings Plan with up to 4% matching contribution
  • Flexible work schedule for most office staff
  • Generous paid time off, including ten company holidays, paternity/maternity leave, and bereavement leave
  • Employee Stock Ownership Program (ESOP)
  • Home office improvement incentives for remote workers
  • Awards and recognition
  • Professional development and training opportunities
  • Two different schedules for production employees
    • 1st shift: M-F 5:45am – 2:15pm
    • 2nd shift: M-Th 2:15pm – 12:45am (includes differential pay)

Our Vision

To be the supplier of choice for single-use disposables within cell and gene therapy.

Our Credo

While our primary responsibility is to the patients who ultimately receive our product, our second responsibility is to our staff, the men and women who work for OriGen. We believe each employee should have a sense of security in their job, fair and adequate wages, as well as clean and orderly working conditions. Management must be qualified and just, and the working environment pleasant.

Core Values

  • Be an example of Corporate Responsibility
  • Demonstrate excellence in all aspects of the company
  • Foster incremental innovation
  • Provide unparalleled customer service
  • Advancement opportunity based on merit
  • Our work should benefit the community and the world

What Makes Working at OriGen Unique

We not only improve the lives of our customers and their patients, but we also try to improve the lives of our own employees by fostering good company culture. OriGen offers a friendly workplace, where individuals treat each other with respect and kindness. Meaningful interactions between colleagues are encouraged. We are always looking to nurture talent and provide opportunities to progress, which is why we often fill available roles from within.

OriGen frequently offers fun in-office activities, lead by the Culture Club, whose sole mission is to provide fun ways for employees to engage with one another.

We are a woman-led business and strive to provide an inclusive workplace for all employees no matter their age, race, gender, ethnicity, religion, sexual orientation, differing abilities, or veteran status.

Safety and Pandemic Protocols

OriGen Biomedical manufactures essential, life-saving products.  As such, OriGen is an essential business and some jobs may be required to work onsite. Your health and safety is important, and while we take pride in our everyday practices to maintain a clean and sanitary environment within our facilities, at present, we have implemented additional measures that reflect the recommended standards of the Centers for Disease Control and Prevention (CDC) in response to the coronavirus.

If needed or desired, masks are available to all employees. Continuous sanitization and cleaning measures are done throughout the day. Workstations and desks are arranged in a manner to maintain a distance of 6 feet.

OriGen has maintained operations throughout the entirety of the pandemic to date, adjusting and adapting as necessary.

Our Mission: We create innovative medical products which improve people’s lives.