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.

Current Job Openings:

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

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 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 office environment is usually minimal.

Salary:

Commensurate with Experience

Manufacturing Engineer

Position Summary

The Manufacturing Engineer 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 Functions and Responsibilities

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

  • Design, evaluate, implement and monitor processes and operating systems for the manufacture of medical devices.
  • Monitor and improve the efficiency, output, and safety of manufacturing processes through observations and measurements, including analyzing and balancing manufacturing lines, space requirement, and equipment layout.
  • Select, develop, validate, setup and maintain manufacturing processes, equipment, and tooling.
  • Provide manufacturing decision-making information by calculating production, labor, and material costs; reviewing production schedules; estimating future requirements.
  • Assist with the install and optimization of automation equipment.
  • 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 manufacturing non-conformances and deviations including risk-assessment.
  • Properly document activities in accordance with best engineering practices, company procedures and cGMP, FDA, and ISO 13485 regulatory requirements.
  • Follow good project management practices.
  • Interface with external vendors to source equipment and fixtures.
  • 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.
  • Ability to design and implement simple fixtures for manufacturing.
  • Write manufacturing standard operating procedures.
  • Keeps equipment operational by coordinating maintenance and repair services; following manufacturer’s instructions and established procedures; requesting special service.

Competencies

  • IQ/OQ/PQ of equipment and processes
  • Risk management (FMEA, pVMP)
  • Test Method Validation
  • Statistical Process Control
  • Technical Capacity
  • Risk-based decision making

Desired Traits

  • Dealing with complex problems
  • Open and approachable
  • Curious
  • Creative with problem solving
  • Leadership
  • Adaptable
  • Data-driven
  • Interpersonal skills
  • Self-Awareness and emotional intelligence
  • Stress Management

Minimum Qualifications (Knowledge, Skills, and Abilities)

  • Bachelor’s degree in Engineering and/or equivalent, directly relevant job experience.
  • 4 years’ experience in a manufacturing environment.
  • Experience installing and qualifying equipment.
  • Experience designing fixtures based on manufacturing input.
  • Skills with 3D modeling software (SolidWorks).
  • Experience with equipment resource set-up in Enterprise Resource Management software (ERP).
  • Management of individual or small-team manufacturing projects.

Preferred Qualifications

  • Experience in medical devices or similarly regulated industry (pharmaceuticals, food, chemical, etc.)
  • Demonstrable knowledge of automation and implementation experience strongly preferred
  • Experience with SolidWorks (3D modeling) and Epicor (ERP) a plus

Supervisory Responsibility

This position has no supervisory responsibilities; however, the individual may be required to lead 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, 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.

Salary:

Commensurate with Experience

Cleanroom Supervisor for Medical Device Production - Evening Shift

Position Summary

The CR Supervisor ensures that all areas of product assembly, testing and packaging are all following Origen’s cGMP and EN/ISO 9001 policies and procedures. This is to be accomplished through proper assembler training, certification, team building and paying attention to details. This position entails working on established products; although there will be occasions that new product development will be built for engineering qualification and validation. Plan and deliver production requirements for OriGen products

Essential Duties and Responsibilities

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

  • Manage production by supervising building sub-assemblies or complete assemblies.
  • Direct supervision of Line Leads and operators to ensure timely closure of build lots with proper documentation and reconciliation of manufacturing lots produced.
  • Take ownership of manufacturing in the clean room from; Line clearance to final assembly including testing and packaging, processing documentation, sterilization, inventory to the warehouse. Build requirements will include Production, Engineering, R&D and Rework.
  • Maintain OriGen’s training procedures and certification for operators as well as encouraging a safe and pleasant working environment.
  • Create weekly schedule for the clean room builds and prioritize builds as required.
  • Processing and documenting product assembly and packaging in accordance with cGMP and EN/ISO 9001 requirements according to OriGen’s internal policies and procedures.
  • Provide daily report on clean room builds with detail failure modes and support root cause analysis.
  • Support design and process verification/validation testing and reporting, and suggest design or process improvement ideas for cost reduction or quality improvement.
  • Support development of MP’s for new products and review them for accuracy.
  • Perform and document testing following protocols; provide evaluation report to engineering.
  • Ensure that all responsibilities within the scope of this job comply with the OriGen Quality System.
  • Handle manufacturing related documentation including ECOs, BOMs, Rework Instructions, NCR’s, and CAPA’s.
  • Ensure clean room supplies inventory is maintained at adequate level, and all equipment in use is calibrated and operational.
  • Timely documentation of manufacturing lots and support of closing work orders.
  • Coordinating proper resource allocation according to weekly production schedule.
  • Ensure MP and Router conformance for GMP and EN/ISO standards in work area.
  • Ensure daily instructions and process changes are understood and followed.
  • Make sure operators have sufficient work materials to complete tasks and/or notify proper people.
  • Ensure material and documentation availability with operators for production builds.

Required Skill Sets

  • Requires a 2 year Technical Degree and 3+ years’ Manufacturing/Assembly supervisory experience.
  • Must have the ability to organize, prioritize and work with a wide variety of people.
  • Supervisory experience in medical devices is highly preferred as is a 4-year Technical Degree

Competencies

  • Strong communication skills both verbal and written
  • Basic arithmetic
  • Well developed problem solving skills to make sound technical decisions
  • Microsoft Office, Agile, SAP
  • 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
  • To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required

Supervisory Responsibility

Daily staffing and production lot number assignments, delegating tasks to line leads and operators. Supervise and train line leads and operators for build requirements in Austin. Evaluate and complete appraisals for line leads and operators in accordance with OriGen’s standard process.

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 Supervisor for Medical Device Production - Morning Shift

Position Summary

The CR Supervisor ensures that all areas of product assembly, testing and packaging are all following Origen’s cGMP and EN/ISO 9001 policies and procedures. This is to be accomplished through proper assembler training, certification, team building and paying attention to details. This position entails working on established products; although there will be occasions that new product development will be built for engineering qualification and validation. Plan and deliver production requirements for OriGen products

Essential Duties and Responsibilities

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

  • Manage production by supervising building sub-assemblies or complete assemblies.
  • Direct supervision of Line Leads and operators to ensure timely closure of build lots with proper documentation and reconciliation of manufacturing lots produced.
  • Take ownership of manufacturing in the clean room from; Line clearance to final assembly including testing and packaging, processing documentation, sterilization, inventory to the warehouse. Build requirements will include Production, Engineering, R&D and Rework.
  • Maintain OriGen’s training procedures and certification for operators as well as encouraging a safe and pleasant working environment.
  • Create weekly schedule for the clean room builds and prioritize builds as required.
  • Processing and documenting product assembly and packaging in accordance with cGMP and EN/ISO 9001 requirements according to OriGen’s internal policies and procedures.
  • Provide daily report on clean room builds with detail failure modes and support root cause analysis.
  • Support design and process verification/validation testing and reporting, and suggest design or process improvement ideas for cost reduction or quality improvement.
  • Support development of MP’s for new products and review them for accuracy.
  • Perform and document testing following protocols; provide evaluation report to engineering.
  • Ensure that all responsibilities within the scope of this job comply with the OriGen Quality System.
  • Handle manufacturing related documentation including ECOs, BOMs, Rework Instructions, NCR’s, and CAPA’s.
  • Ensure clean room supplies inventory is maintained at adequate level, and all equipment in use is calibrated and operational.
  • Timely documentation of manufacturing lots and support of closing work orders.
  • Coordinating proper resource allocation according to weekly production schedule.
  • Ensure MP and Router conformance for GMP and EN/ISO standards in work area.
  • Ensure daily instructions and process changes are understood and followed.
  • Make sure operators have sufficient work materials to complete tasks and/or notify proper people.
  • Ensure material and documentation availability with operators for production builds.

Required Skill Sets

  • Requires a 2 year Technical Degree and 3+ years’ Manufacturing/Assembly supervisory experience.
  • Must have the ability to organize, prioritize and work with a wide variety of people.
  • Supervisory experience in medical devices is highly preferred as is a 4-year Technical Degree

Competencies

  • Strong communication skills both verbal and written
  • Basic arithmetic
  • Well developed problem solving skills to make sound technical decisions
  • Microsoft Office, Agile, SAP
  • 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
  • To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required

Supervisory Responsibility

Daily staffing and production lot number assignments, delegating tasks to line leads and operators. Supervise and train line leads and operators for build requirements in Austin. Evaluate and complete appraisals for line leads and operators in accordance with OriGen’s standard process.

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 5:45am – 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 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