Cleanroom Production Specialist

2 weeks ago


Ayer, Massachusetts, United States Astrix Technology Full time

Position: Cleanroom Production Specialist

Industry: Clinical

Company: Astrix Technology

Job Type: Contract to hire

Compensation: $21.42/hr

Overview:

Astrix Technology is seeking a dedicated Cleanroom Production Specialist to join our team. As a leader in the biopharma and healthcare sectors, we are committed to advancing technologies that make a global impact.

Key Responsibilities:

  • Execute the assembly, sanitation, and packaging of various Single-Use systems in accordance with Engineering Process Records (EPR), schematics, and Standard Operating Procedures (SOP).
  • Utilize appropriate personal protective equipment (PPE) and promptly report any near misses or first aid incidents.
  • Adhere to cleanroom standards and current Good Manufacturing Practices (cGMP) to uphold an ISO Class 7 environment.
  • Actively engage in continuous improvement initiatives and comply with change control protocols.
  • Identify and escalate potential process or product deviations to mitigate waste, rework, and customer returns.
  • Maintain daily organization (6S) and cleanliness of both personal and shared workspaces.
  • Support inventory accuracy by returning unused components to stock in sealed packaging with part numbers and lot traceability.
  • Participate in and comply with ISO 9001:2015 quality standards across all manufacturing areas to meet company quality objectives.
  • Ensure adherence to internal manufacturing timelines to facilitate on-time delivery.
  • Complete and sign off on EPRs for each task performed during assembly.
  • Achieve assembly goals within the designated timeframes outlined in work orders.
  • Promote a culture of quality by instilling a 'build it right the first time' mindset.
  • Perform additional duties as assigned.

Qualifications:

  • High School diploma or equivalent (GED).
  • 1-2 years of experience in a production role within a cleanroom setting.
  • Familiarity with cleanroom operations, engineering drawings, and Lean manufacturing principles.
  • Excellent communication skills.
  • Commitment to safety and quality in all tasks.

We are an equal opportunity employer, and all qualified candidates will be considered for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.


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