OriGen Biomedical Open Jobs

POSITION SUMMARY

The Clinical Specialist plays a pivotal role at the intersection of sales, marketing, regulatory affairs, engineering, and quality affairs within our organization. Reporting directly to the Director of Global Business Development, this position serves as a crucial liaison with various departments including Regulatory, Quality, Engineering, Customer Service, and Marketing at our corporate offices in Austin, TX.

ESSENTIAL DUTIES AND RESPONSIBILITIES

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

• Develop a broad-based technical capability at OriGen to gain knowledge and experience in the applications of our products to enable us to better inform our customers about their proper use
• Ability to create and deliver presentations to customers online and in person as required
• Act as technical liaison for information transfer between customers and appropriate OriGen Departments. Example Sales, Engineering, Production, QA/RA, Marketing
  • This includes but is not limited to technical input on current or future design and development projects
• Participate in the development of an educational curriculum for OriGen
• This will include but is not limited to online education, in-house seminars, regional training at other locations, as well as technical presentations and workshops at various professional association meetings
• To assist in the preparation of technical/clinical articles on various OriGen products and techniques for publication
• To interact and provide technical support to internal Stakeholders
• Provide education and training to internal Stakeholders
• Assist customers in the clinical environment by educating, directing care, or assisting with applications of our products and techniques
• Assist with strategic customer visits

REQUIRED SKILLSETS

• Must be detail-oriented
• Must be proficient on a computer, possessing advanced navigation and program knowledge

COMPETENCIES

• Self-starter managing day-to-day tasks and working in collaboration to accomplish deadlines and objectives
• Interpersonal skills necessary for working effectively in a team environment
• Works cross-functionally to complete projects and testing
• Exercises judgment and makes sound decisions within broadly defined practices and policies
• High emotional intelligence and ability to navigate conflict and complex issues
• Problem-solver at all organizational levels – focused on what is best for OriGen
• Outstanding communication skills, both written and oral, in communicating across and outside of the organization
• Ability to actively listen, evaluate alternatives, and articulate options, thoughts, and ideas
• High personal and professional integrity and emotional maturity
• Able to accept positive and constructive feedback with grace, interest, and poise
• Strong ability to influence and persuade

MINIMUM QUALIFICATIONS (KNOWLEDGE, SKILLS, & ABILITIES)

• 2+ years experience working with our products or similar
• 2+ years working in a cell therapy lab
• Bachelor’s degree in life sciences
• Knowledge of regulations and guidelines for medical device sales and marketing
• Demonstrated ability to use effective and results-oriented problem-solving and critical-thinking skills
• Strong ability to understand and interpret customer needs; customer-centric; ability to proactively work with diverse work teams
• Strong interpersonal and people skills
• Strong organization and time management skills with the demonstrated ability to meet deadlines
• Outstanding communication skills (verbal and written)
• Ability to work independently and within a team environment on assigned projects from inception to completion
• Knowledge of FDA regulations and guidelines for medical device process validation.
• Proven skills in coordinating and managing day-to-day tasks and working in collaboration to accomplish deadlines and objectives.
• Proficiency in technical and layman writing.
• Thrives in a team environment
• Proficiency in using computer software applications including Microsoft Office Suite, Salesforce, G-Suite, and Asana.
• High aptitude for learning new technical information, products, and their applications

PREFERRED QUALIFICATIONS

• Bachelor’s degree in Microbiology
• 5+ years’ experience working with our products or similar
• 5+ years working in a cell therapy lab

SUPERVISORY RESPONSIBILITY

This position has no supervisory responsibilities. However, it may require leading/reporting on projects and ensuring participants meet deadlines.

WORK ENVIRONMENT

This job operates in a climate-controlled warehouse and/or professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets, and fax machines. The noise level in the work environment is generally moderate however periods of higher-level noise may occur.

This job may also operate in a cleanroom environment. The cleanroom environment requires personnel to wear personal clothing completely covering the legs; company-provided cleanroom attire; e.g. coat, bouffant, face mask, and gloves.

• Must be able to stand or sit for extended periods. Must be able to wear personal protective equipment when required

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 frequently required to stand, walk, climb, sit, stoop, bend, and reach with hands and arms. The employee must frequently lift and/or move up to 50 pounds and may be required to operate automated warehouse equipment; e.g. electric pallet jack, or forklift. Specific vision abilities required by this position include close vision, distance vision, color vision, and the ability to adjust focus.

Travel

10-15%

Salary:

Position Summary

The Quality Engineer I is responsible for technical duties within the Quality organization including validation and qualification,  calibration, and customer contact. These duties will support manufacturing operations, customer service, process improvement, and  regulatory requirements.

ESSENTIAL DUTIES AND RESPONSIBILITIES

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

• Plan and coordinate microbiological programs within the Quality department, including:
  • Bioburden monitoring per ISO 11737-1
  • Pyrogen monitoring per USP<161> and <85>
  • Cleanroom qualification ISO 14644
• Consult on microbiological aspects of sterilization qualification, including:
  • Gamma per ISO 11137
  • Ethylene Oxide per ISO 11135
• Perform routine complaint investigations and draft summary reports to customers.
• Develop Root Cause Analysis on problems originating from many sources, from production to end-user, including ownership of CAPAs and Nonconformance reports (NCR).
• Technical writing to include standard operating procedure (SOP) document, test protocols, and test reports, investigational summaries, risk assessment, and assistance with regulatory submissions.
• Support with process and design verification and validation activities.
• Execute risk assessment per ISO 14971 including risk planning, data collection, prediction of hazards and hazardous situations, and reporting.

Other duties and/or projects as assigned.

REQUIRED SKILLSETS

• Must be detail-oriented
• 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

• Self-starter
• Good math, technical writing and computer skills
• Close attention to detail
• DOE and validation testing
• Familiar with quality tools and procedures
• Broad creativity and curiosity
• Organizational and time management skills
• Seasoned problem-solving skills
• Ethical Conduct
• Communication and interpersonal skills
• Can work with changing priorities
• Adaptability
• Results-driven
• Decision making

MINIMUM QUALIFICATIONS (KNOWLEDGE, SKILLS, & ABILITIES)

• Bachelor’s degree in Engineering or 1 – 2 years’ experience in medical device quality / ISO 13485
• Demonstrated ability to use effective and results-oriented problem solving and critical thinking skills; hands-on troubleshooting ability
• Ability to understand and interpret customer needs; ability to work with all work functions (i.e. Regulatory, Operations, Human Resources, Engineering)
• Ability to work independently and lead or participate in a team environment

PREFERRED QUALIFICATIONS

• 3-5 years’ experience in medical device quality / ISO 13485
• 2+ years’ experience in a manufacturing environment Knowledge of Lean concepts

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 climate-controlled warehouse and/or professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets, and fax machines. The noise level in the work environment is generally moderate however periods of higher-level noise may occur.

This job may also operate in a cleanroom environment. The cleanroom environment requires personnel to wear personal clothing completely covering the legs; company-provided cleanroom attire; e.g. coat, bouffant, face mask, and gloves.

• Must be able to stand or sit for extended periods. Must be able to wear personal protective equipment when required.

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 frequently required to stand, walk, climb, sit, stoop, bend, and reach with hands and arms. The employee must frequently lift and/or move up to 50 pounds and may be required to operate automated warehouse equipment; e.g. electric pallet jack, or forklift. Specific vision abilities required by this position include close vision, distance vision, color vision, and the ability to adjust focus.

Salary:

The QA Technician Inspector I works with limited supervision to conduct incoming, in-process, and final product inspection; support the control and disposition of nonconforming materials and supplier corrective actions; calibrate equipment; create, finalize and maintain quality records; process customer returns; and print product labels.

Reporting directly to the QA Manager, this individual will interface daily with Manufacturing, Operations, Research and Development, Customer Service, and Marketing in our corporate offices in Austin, TX.

ESSENTIAL DUTIES AND RESPONSIBILITIES

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

• Performs inspections of incoming, in-process, and final product for conformance to quality assurance standards using an approved sampling plan.
• Accurately completes all quality control documentation and inspection sheets in accordance with ISO 13485 Standard and established procedures.
• Verify inspection equipment, machinery and tools used are calibrated per company policy.
• Follows verbal and/or written instructions such as production traveler, work instruction, process specifications, and drawings at the direction of supervisor in completing a variety of inspection tasks.
• Makes decisions as to the acceptable quality; determines reasons for rejection; completes required quality records.
• Identify, initiate quarantine, report and document all nonconforming product.
• Bring problems/issues to attention of Management.
• Work efficiently to achieve targeted goals as set by the production schedule.
• Participates and/or assists with cross training activities, training of new hires and temporary staff.
• Follows set training program for position and ensures training requirements are up to date.
• Demonstrates safe work habits, maintain clean and safe work area.
• Performs other duties as assigned, to maintain efficiency throughout the company.
• Conducts equipment calibration activities, requiring a good understanding of current metrology practices and use of measuring instruments.

COMPETENCIES

• Self-starter
• Close attention to detail
• Ability to perform product inspections, including understanding of drawing dimensions and tolerances.
• Understanding of the selection and use of sampling plans.
• Familiar with quality tools and procedures
• Creativity and curiosity
• Organizational and time management skills
• Good math, technical writing and computer skills.

MINIMUM QUALIFICATIONS (KNOWLEDGE, SKILLS, & ABILITIES)

• High school diploma
• 1 + years’ experience working within a formalized FDA or ISO Quality System
• 1 + years’ experience within a medical device manufacturing environment

PREFERRED EDUCATION AND EXPERIENCE

• Associate degree or professional certification

SUPERVISORY RESPONSIBILITY

This position has no supervisory responsibilities; however, the individual may be required to lead projects and ensure participants meet deadlines.

POSITION TYPE, EXPECTED HOURS AND TRAVEL

• This is a full-time position required to work onsite.
• Days and hours of work are typically Monday through Friday, 8:30 a.m. to 5 p.m. In some cases, additional work hours may be required.
• 5- 10% travel as needed.

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 periodically 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 & 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. 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 periodically 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:

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 origenjobs@origen.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.

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). 

Position Summary

The Warehouse Packer is responsible for performing operations tasks within our fulfillment center in Austin, TX. Required to understand and comply with drawings, written procedures, batch records and apply these standards to their work. The individual will be required to participate in tasks associated with receiving, handling, storing, picking, and packing within the warehouse, ensuring quality standards are met. The individual will be required to perform inventory counts.

Essential Duties and Responsibilities

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

• Visually inspect products to specification including particulate matter and other product specific requirements
• Read and interpret product drawings
• Perform accurate counts of products to specification
• Assemble cartons, boxes and other packaging for final products
• Utilize pallet jacks, carts and dollies for movement of materials
• Assist with additional material requests from production teams
• Follow gowning requirements for obtaining and delivering materials from and to the production clean rooms
• Assist with all shipping and receiving related to the manufacturing activities.
• Ensure that all responsibilities within the scope of this job comply with the scope of the OriGen Quality System.
• Other duties and/or projects as assigned

Required Skill Sets

• Must be detailed oriented
• 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

• Punctual
• Reliable
• Adaptability/Flexibility
• Ethical Conduct/Integrity
• Communication/Listening
• Detail-Oriented
• Interpersonal skills
• Personal Effectiveness and a positive attitude
• Teamwork

Minimum Qualifications (Knowledge, Skills, and Abilities)

•  High school diploma or GED
• Experience in an ERP System (Epicor preferred),
• Experience with Microsoft Excel
• Able to review and analyze discrepancies
• Ability to work independently and within a team environment
• Excellent problem-solving skills, communication and leadership qualities
• Ability to work with all levels of company staff

Preferred Qualifications

•  Prior warehouse experience
• Proficient knowledge of warehouse procedures and policies
• Knowledge of warehousing Key Performance Indicators (KPIs)
• Knowledge of Lean concepts

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 climate-controlled warehouse and/or professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. The noise level in the work environment is generally moderate however periods of higher-level noise may occur.

This job may also operate in a cleanroom environment. Cleanroom environment requires personnel to wear personal clothing completely covering the legs; company-provided cleanroom attire; e.g. 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

 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, climb, sit, stoop, bend and reach with hands and arms. The employee must frequently lift and/or move up to 50 pounds and may be required to operated automated warehouse equipment; e.g. electric pallet jack, forklift. Specific vision abilities required by this position include close vision, distance vision, color vision, and the ability to adjust focus.

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 origenjobs@origen.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.

If you are interested in working at OriGen, but do not see a current opening that fits your skillset, please use the form below and you’ll be notified if a similar role becomes available.

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