Job description

The Cleanroom Operations Specialist assists and operates under the direction of the Director, Cleanroom Operations, or designee. The Cleanroom Operations Specialistmust support proper cleanroom operations, policies, procedures, work instructions, and lead daily operations work staff in Cleanroom operations. This role must maintain and ensure Regulatory Compliance in every work task. In the absence of the Director, Cleanroom Operations Specialist (OS) shall initiate manufacturing orders and assign priorities to the Production team. The Cleanroom OS must support proper cleanroom operations, policies, procedures, work instructions, and lead daily operations work staff in Cleanroom operations.

Essential Duties and Responsibilities:

• Operations
• Assist in performing tasks as assigned by, the Director, Cleanroom Operations
• Attend Daily Operations meeting as needed and present when management is not available
• Assist visitors with protocols for tours
• Safety, Quality, and Regulatory Compliance:
• Maintain a Safe work environment, Product Quality, On-Time Delivery, adherence to regulated products in a regulated environment.
• Responsible to preparing, reviewing, updating, and submitting, Safety Work Instructions.
• Adhere to the Quality Management System and support all quality initiatives.
• Prepare, review, submit, update Work Instructions related to all equipment and cleanrooms. Perform, document, write work instructions, teach, coach, and maintain proper cleaning processes and procedures for Cleanroom Operations and automated equipment.
• Train new employees in critical job duties.
• Perform and be actively engaged in Annual and Unplanned Shutdowns, and other events that adversely affect operational status.
• Perform or oversee Cleanroom and equipment cleaning for shift transfers, daily, weekly, monthly, quarterly, and annual events as needed.
• Maintain regulatory batch records as required for each operational task and assigned equipment.
• Manufacturing:
• Assume Lead Ops role for Item Set Up, Line Clearing, Line Set Up, Equipment Set up, Equipment Shutdown, and Cleanroom Daytime/Nighttime operational settings.
• Manage the Manufacturing Order Pick list, pull and set up components for operations and completed items. Transfer products between workstations and storage locations. Weigh count and record components. Track labor using the MO system.
• Operate and understand operational and process equipment, demonstrate the ability and desire to learn new systems, such as washing, assembly, sealing, scanners, label printers, and barcode readers.
• Continuous Improvement
• Required to engage in continuous improvement activities, new product launches, automation program equipment launches, Kaizen events, Lean events, Strategy events, and other Daily Improvement activities.
• Supply Chain and Material Handling
• Maintain inventory integrity via careful handling of components and perform audits per requirements or special situations.
• Work as a member of the Production team in conjunction with all materials coordination activities, including external and internal vendors.

Qualifications:

• Experience using or the ability to learn Microsoft Great Plains Dynamics (or equivalent experience in MRP/ERP software such as SAP or Oracle or JD Edwards) to initiate/change Manufacturing Orders, track inventory status, etc.
• Medical industry related assembly experience preferred.
• Cleanroom operations experience preferred
• Must be detail oriented, able to follow directions and adhere to procedures in a structured work environment.
• Must provide situational leadership including problem solving skills
• Experience with Microsoft Office Suite Required including Excel
• Must be able to work in and maintain a cleanroom environment utilizing required garments and PPE.

Education:

• Bachelor’s Degree preferred and/or combination of experience.
• Minimum 5 years’ experience in a production or shop environment is preferred.
• Medical Device manufacturing preferred.
• Cleanroom manufacturing experience preferred.
• ASQ Certified Quality Tech or Certified Quality Auditor Online Certifications required within 2 years of placement.
• Parenteral Drug Association Training in key areas of responsibility required in 4 years.

BENEFITS:

• 2 comprehensive medical plan options to choose from available the first of each month following your date of hire
• Flexible Spending Account or HSA Account available
• Vision Benefits
• Company paid Dental Insurance for employee and dependents
• Wellness Plan
• 401k with 5% matching
• Generous PTO plan including 11 paid holidays, 2 Floating Holidays and Community Service Hours
• Company paid Short Term Disability
• Long Term Disability
• Company provided Life Insurance
• Paid Parental Leave
• Casual Dress Code
• Social events for employees and family

Henry Schein, Inc. is an Equal Employment Opportunity Employer and does not discriminate against applicants or employees on the basis of race, color, religion, creed, national origin, ancestry, disability that can be reasonably accommodated without undue hardship, sex, sexual orientation, gender identity, age, citizenship, marital or veteran status, or any other legally protected status.

Please note that any offer of employment made by BioHorizons is contingent upon the successful completion of a pre-employment background investigation to include a pre-employment drug screen.

Job Type: Full-time

Pay: From $17.00 per hour

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Professional development assistance
• Referral program
• Vision insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Supplemental pay types:

• Bonus pay

Ability to commute/relocate:

• Birmingham, AL 35244: Reliably commute or planning to relocate before starting work (Required)

Experience:

• Manufacturing: 1 year (Preferred)

Shift availability:

• Day Shift (Required)

Work Location: One location

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