Cleanroom Technical Lead (2nd Shift 3:00p-11:30p) jobs in United States
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Comar · 2 months ago

Cleanroom Technical Lead (2nd Shift 3:00p-11:30p)

Comar is a company focused on manufacturing and production, and they are seeking a Cleanroom Technical Lead to provide strategic direction and training across the organization. The role involves leading troubleshooting activities, ensuring compliance with safety and FDA regulations, and serving as the point of contact for communication during shift changes.

Health CarePackaging Services
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H1B Sponsor Likelynote

Responsibilities

Lead equipment troubleshooting activities
Assist in maintenance activities as needed
Fill in for Supervisor when necessary
Ensure safety, FDA rules & GDP Regulations are enforced
Monitor Associates and machines for safety
Maintain area of responsibility with proper 5S
Auditing paperwork
Operate machines as assigned during shift, unless filling-in for the Supervisor
Crew trainer, including new employee onboarding
Be the point of contact for all communication
Coordinate communication of details across shift changes
Escalate downtime events to Supervisor, Maintenance, Engineering and Management as needed
Perform/Verify IQMS downtime and scrap reporting
Perform production reporting
Update visual plant metrics
Check schedule changes and any impacts
Assist with quality holds, MRBs, and corrective actions as needed

Qualification

ISO 9001 experienceISO 13485 experienceTechnical aptitudeProduction data entryMeasuring devices proficiencyCommunication skillsOrganizational skillsProblem-solving skillsSelf-motivated

Required

Lead equipment troubleshooting activities
Assist in maintenance activities as needed
Fill in for Supervisor when necessary
Ensure safety, FDA rules & GDP Regulations are enforced
Monitor Associates and machines for safety
Maintain area of responsibility with proper 5S
Auditing paperwork
Operate machines as assigned during shift, unless filling-in for the Supervisor
Crew trainer, including new employee onboarding
Be the point of contact for all communication
Coordinate communication of details across shift changes
Escalate downtime events to Supervisor, Maintenance, Engineering and Management as needed
Perform/Verify IQMS downtime and scrap reporting
Perform production reporting
Update visual plant metrics
Check schedule changes and any impacts
Assist with quality holds, MRBs, and corrective actions as needed
Log in to IQ and enter production data and complete production forms (batch record)
Read, understand and follow documents such as safety rules, operating & maintenance instructions, and procedures
Apply basic math skills: add, subtract, multiply, and divide
Carry out instructions provided in written, oral, or visual/diagram form
Self-motivated, conscientious, with a results-oriented mindset
Good organizational and communication skills to work independently and also in a team environment
Ability to use measuring devices such as Comparator, Dial indicator, Go/No Go gauges
Ability to work in a fast-paced manufacturing environment with demonstrated ability to handle and prioritize multiple tasks and demands
Strong technical aptitude, as well as analytical and problem-solving skills to trouble shoot and solve problems
Sound judgment - ability to work efficiently with many competing demands
Ability to communicate their job-related functions with other employees, customers and auditors as needed
While performing the duties of this job, the employee is regularly required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear
The employee frequently is required to climb or balance and stoop, kneel, crouch, or crawl
The employee must regularly lift and/or move up to 10 pounds, occasionally lift and/or move up to 50 pounds
Specific vision abilities required by this job include close vision, depth perception, and ability to adjust focus
The employee is regularly exposed to moving mechanical parts
Manufacturing environment
The noise level in the work environment is usually loud

Preferred

3-5 years prior experience as a production operator, technician and/or maintenance
Additional education related to vo-tech, operations or manufacturing field
Prior experience in ISO 9001 and/or IS13485 manufacturing environment
Internal: perform current role at or above target with no disciplinary action on file for at least 90 days

Benefits

Medical
Dental
401(k)
Tuition reimbursement
Additional ancillary benefits available upon request

Company

Comar

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Comar is a specialty packaging and dispensing provider.

H1B Sponsorship

Comar has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (4)
2023 (1)

Funding

Current Stage
Late Stage
Total Funding
unknown
2025-11-04Acquired
2021-12-01Private Equity
2018-06-19Private Equity

Leadership Team

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Brian Larkin
President and Chief Executive Officer
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Company data provided by crunchbase