Founded in 1997 and headquartered in Austin, Texas, OriGen Biomedical is a privately-held medical device manufacturer that is experiencing growth. Our company is a leading producer of cryopreservation and cell culture products with a focus on developing a range of solutions to support the treatment of life-threatening diseases such as cancer and genetic conditions. Our products are designed with both the patient and user in mind, and we take pride in our commitment to providing excellent customer service to ensure patient care always remains our top priority. The primary way to achieve this is by attracting and hiring the right people who 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.

Cleanroom Line Lead - Second Shift

The Clean Room Line Lead is responsible for leading and directing the CR team in assembly, testing and packaging of medical devices and components. Role is required to understand and comply with drawings, written procedures, batch records and apply these standards to their work.

As a team lead, you will be the main contact point for all team members. You will possess the ability to be a team player, team leader and are expected to timely escalate issues to management for resolution. You should lead by setting a good example and engage and motivate the team to achieve daily goals. You will oversee production processes in accordance with OriGen’s policies and procedures.

Essential Duties and Responsibilities

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

  • Daily CR Shift Setup:
    • Equipment inspection and start-up
    • Daily log review/completion
    • Priority assessment and assignment
    • Shift pass down – verify all paperwork is filled out before passing on
  • Report problems or concerns with quality, processes, equipment, materials and staffing to Operations Manager or designee.
  • Meet production schedules and deadlines while maintaining quality standards
  • Work in a flexible and changing environment
  • Communicate, delegate and motivate in a positive manner
  • Lead and motivate team members to meet production goals
  • Follow detailed written and verbal instructions
  • Aid in training members on assembly processes and answers related questions from team
  • Effectively communicate daily concerns and issues with others and management during shift and at shift change
  • Learn multiple tasks and train in other areas as needed
  • Work with a variety of tools and equipment
  • Maintain all logs, paperwork and forms accurately
  • Understand, access and make entries to documents on the company Electronic Document System
  • Accurately perform job duties with minimum supervision
  • Adhere to cleanroom dress code and policies
  • Work in a multi-cultural team environment and be a team player
  • Work in a cleanroom environment for extended periods of time
  • Must be punctual, reliable and willing to lead by example

Required Skill Sets

  • Detailed oriented and able to focus on repetitive tasks for long periods of time
  • Proficient on computer; possessing basic navigation and program knowledge
  • 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/Team Leadership

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
  • Close attention to detail
  • Ability to work independently and within a team environment
  • Prior Clean Room experience

Preferred Qualifications

  • Prior experience in a lead position is preferred

Supervisory Responsibility

This position has no direct supervisory responsibilities although the role will be responsible for daily work/task assignment and oversight.

Work Environment

This job often operates in a cleanroom environment. Cleanroom environment requires personnel to wear personal clean and non-frayed pants/scrubs completely covering the legs and/or a full pants/body “bunny suit”. Personnel may also be required to wear company-provided cleanroom coat, bouffant, face mask, and gloves.

  • Must be able to stand or sit for extended periods of time. Must be able to wear personal protective equipment when required.
  • Due to extremely detailed nature of work, may be required to submit to periodic post-employment vision screening and be willing/able to wear corrective eye wear if deemed necessary/appropriate.
  • Note: OriGen is a fragrance, smoke, smokeless tobacco and vape-free facility. There is NO use of any tobacco or vape products permitted anywhere on company grounds/property or during any shift, break or lunch period.

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 frequently 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.

Compensation

Based on experience and ability

 

Cleanroom Tech for Medical Device Production - Morning and Evening Shift

Morning Shift: Work hours: five days, 8-hour shifts (Monday-Friday 5:30am – 2:00pm).

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

The Clean Room Tech (CRT) is responsible for the assembly, testing, and packaging of medical devices and components. Required to understand and comply with drawings, written procedures, batch records, and must 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

 

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.

Manufacturing Engineer I

Position Summary

The Manufacturing Engineer I will evaluate and develop processes to ensure quality, cost, and efficiency requirements are met. S/he will troubleshoot problems with production and take corrective actions and will research and make recommendations on the purchase of equipment and/or upgrades to existing equipment and support manufacturing as needed.

ESSENTIAL DUTIES AND RESPONSIBILITIES

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

  • Write and execute incoming, operation and performance qualification protocols for new and existing

    equipment.

  • Use root cause analysis methods to determine root causes for complex problems and develop corrective

    and preventative actions (CAPAs) to address any deficiencies.

  • Perform process risk assessments for equipment and manufacturing processes per ISO 14971:2019.
  • Participate in the Site Validation Master Plan team.
  • Utilize a computerized Quality Management System (cQMS) to author documentation changes, nonconformance reports and CAPAs.
  • Troubleshoot equipment requiring unplanned maintenance or repair, including risk assessment.
  • Updates product and material drawings as needed.
  • Use technical writing to create, update, implement and improve procedures.
  • Select, develop, validate, setup and maintain manufacturing processes, equipment, and tooling.
  • Design, evaluate, implement and monitor processes and operating systems for the manufacture of medical

    devices.

  • Develop and present project proposals to a diverse group of stakeholders.
  • Monitor and improve the efficiency, output and safety of manufacturing processes through observations

    and measurements as well as by collecting and interpreting data from other technical and operating

    personnel.

  • Improve manufacturing efficiency by analyzing and planning work flow, space requirements, and equipment

    layout.

  • Follow good project management practices.
  • Interface with external vendors to source equipment and fixtures.
  • Review regulatory standards and requirements and apply them to new or current processes.
  • Design and improve production tooling as required.
  • Provide manufacturing decision-making information by calculating production, labor, and material costs;

    reviewing production schedules; estimating future requirements.

  • Assume responsibility for safety/environmental issues and ongoing performance of processes.
  • Stay up-to-date and follow all Quality System procedures related to this job which can affect the quality of

    products or services provided to our customers.

  • Support production through efficient and effective identification and resolution of line issues.
  • Identify, initiate, and execute process, cost reduction and process improvement projects.
  • Properly document activities in accordance with best engineering practices, company procedures and

    cGMP, FDA, and ISO 13485 regulatory requirements.

  • Effectively train operators, technicians, and engineers on use of equipment and fixtures.
  • Participate and drive continuous improvement projects related to manufacturing.
  • Participate in product development teams to provide input from a manufacturing perspective.
  • Prepares product and process reports by collecting, analyzing, and summarizing information and trends.
  • Knowledgeable in medical device GMP processes in an FDA regulated industry.
  • Provides manufacturing engineering information by answering questions and requests.
  • Keeps equipment operational by coordinating maintenance and repair services; following manufacturer’s

    instructions and established procedures; requesting special service.

  • Maintains professional and technical knowledge by attending educational workshops; reviewing

    professional publications; establishing personal networks; participating in professional societies.

  • Contributes to team effort by accomplishing related results as needed.
  • Central contact for Facility and Equipment Maintenance.
  • Other duties and/or projects as assigned

COMPETENCIES

  • Dealing with Complexity/Ambiguity
  • Informing Others/Communication
  • Curious/Creative
  • Self-Starter
  • Leadership
  • Adaptability
  • Results-driven
  • Technical Capacity
  • Ethical Conduct
  • Communication
  • Decision making
  • Interpersonal skills
  • Self-Awareness/EQ
  • Stress Management

MINIMUM QUALIFICATIONS (KNOWLEDGE, SKILLS, & ABILITIES)

  • Bachelor’s degree in Engineering and/or equivalent, directly relevant/compatible job experience
  • 0-2 years’ experience in a small medical device or equivalent manufacturing environment
  • Strong technical writing skills
  • Familiarity with LEAN manufacturing processes
  • Demonstrated ability to use effective and results-oriented problem solving and critical thinking skills; strong

    troubleshooting ability

  • Strong ability to understand and interpret needs from adjacent teams (i.e. Sales, Operations, Regulatory,

    Quality)

  • Strong interpersonal and people skills
  • Demonstrated ability to work with a large team to achieve complex results
  • Strong organization and time management skills with the demonstrated ability to meet deadlines
  • Strong and effective communication skills (verbal and written) with ability to communicate cross-functionally

    and up/down chain

  • Pays very close attention to detail
  • Self-motivated, hands-on with keen interest in quickly learning and applying new skills/concepts
  • Ability to follow written/verbal instructions and meet deadlines with minimal supervision
  • Ability to react quickly to changing requirements and new processing developments
  • Knowledge of and skills in using computer software and hardware applications, including Microsoft Word

    and Excel

PREFERRED QUALIFICATIONS

  • Knowledge of Hardware Specifications, Manufacturing Methods and Procedures
  • Progressive experience related to Manufacturing Quality, Product Development, Presenting Technical

    Information, IQ/OQ/PQ techniques

  • Experience working in a medical device or similarly regulated industry
  • Working/demonstrable knowledge of automation and implementation experience strongly preferred
  • Experience with SolidWorks and Epicor a plus

SUPERVISORY RESPONSIBILITY

This position has no supervisory responsibilities. This position may be required to lead/report on projects 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, and copiers.

  • This job may operate in a cleanroom environment. Cleanroom environment requires personnel to wear

    personal clothing completely covering the arms, torso and legs; company-provided cleanroom clothing.

PHYSICAL DEMANDS & 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

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.

Salary:

Commensurate with Experience

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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 patients’ lives. Our products play a pivotal role in the treatment of a wide range of conditions and life-threatening diseases. Every day, your work will have a meaningful impact on the well-being of individuals around the world. You’ll enjoy a positive, stimulating, and inclusive environment where collaboration and creativity thrive. At OriGen, you’ll find ample opportunities to expand your skills, take on new challenges, and carve out a rewarding career path—all while knowing that your efforts contribute significantly to making a difference in the lives of those we serve.

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
  • Educational Assistance Program for undergraduate, graduate, and post-graduate studies
  • 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 Mission

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

Our Vision

To be the supplier of choice for single-use disposables within cell and gene therapy and to support transformational therapies across the world.

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 Employees are Saying

>85% say that their job makes them feel like they are a part of something meaningful
>85% would highly recommend working at OriGen to others
>85% believe that OriGen is going in the right direction
>80% say that OriGen motivates them to give their very best at work
>80% agree that OriGen operates by strong values
>80% feel genuinely appreciated at OriGen
>80% feel that their manager cares about their concerns
>80% feel included at OriGen
>70% feel that new ideas are encouraged
>70% think OriGen encourages different points of view

via 2023 Energage employee survey

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 led by the Diversity, Engagement, and Inclusion Committee, 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.