1st shift line lead

OriGen Biomedical; Austin (TX); On-site; USD 65,000 - 90,000; Full time

Job summary

OriGen Biomedical, Inc. is seeking a Cleanroom Line Lead to guide the CR team in assembly, testing, and packaging of medical devices. You will ensure compliance with drawings, procedures, and batch records, and motivate the team to meet daily goals.

You will oversee production processes, communicate effectively with management, and train staff while maintaining strict cleanroom standards and documentation accuracy in a fast-paced environment.

Qualifications

• Strong attention to detail and ability to focus on repetitive tasks.
• Proficient computer skills and basic software navigation.
• Excellent written and spoken English.
• Ability to work independently and as part of a team.

Responsibilities

• Lead daily CR shift setup and equipment start-up.
• Review logs and ensure paperwork completion and accuracy.
• Assign tasks and oversee meeting production schedules to hit deadlines.
• Communicate issues and escalate to Operations Manager as needed.
• Train team members on assembly processes and answer related questions.

Skills

Detail-oriented

Computer literacy

Data retention

English proficiency

Job description

Company

OriGen Biomedical, Inc., is a global leader in cryopreservation and cell culture. We collaborate with top researchers, clinicians, and business partners to enhance solutions, improve patient outcomes, and achieve customer satisfaction by providing safe and effective products that positively impact the quality of life.

Position Summary

The Cleanroom 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 elevate 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 Skillsets

• 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, & 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 & 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.

Note

This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employees will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorized to give instructions or assignments. All duties and responsibilities are essential functions and requirements and are subject to possible modification to reasonably accommodate individuals with disabilities. To perform this job successfully, the incumbents will possess the skills, aptitudes, and abilities to perform each duty proficiently. Some requirements may exclude individuals who pose a direct threat or significant risk to the health or safety of themselves or others. The requirements listed in this document are the minimum levels of knowledge, skills, or abilities. This document does not create an employment contract, implied or otherwise, other than an “at-will” relationship.