About The Position

The Technician I, GMP Manufacturing Support, performs a wide range of functions crucial to AAV gene therapy production. This position is responsible for cleaning and sanitization of GMP equipment and facilities, preparing tubing sets and inventory management within the cleanroom space. This entry-level position offers an opportunity to gain foundational experience in the multifaceted support activities crucial for the production of AAV gene therapy products.

Requirements

  • High school diploma or equivalent GED required
  • Experience following SOPs or other protocols/work instructions
  • Basic computer skills and the ability to learn and use manufacturing software
  • Ability to work the hours necessary to support production and/or product transfer activities
  • Ability to work in loud noise environments and in Personal Protective Equipment (PPE) as needed

Nice To Haves

  • Prior experience in a manufacturing or laboratory environment.
  • Exposure to facility or equipment cleaning and sanitization or equipment building and setup.

Responsibilities

  • Perform the cleaning and sanitization of GMP manufacturing facilities and equipment, ensuring compliance with SOPs and cGMP regulations.
  • Assist in tube set preparation under supervision, adhering to specific procedures and documentation practices.
  • Replenish cleaning and consumables supplies required for manufacturing operations, setting reorder points, and placing orders as per forecast demand.
  • Stock and maintain common-use items in the cleanroom, ensuring that inventory levels are adequate for daily operations and that items are readily available.
  • Monitor the expiration dates and conditions of consumables, ensuring that they are rotated and replaced as necessary to prevent shortages or non-compliance.
  • Maintain real-time and accurate documentation; perform the manufacturing review of logbooks, MPR’s, and associated documents.
  • Assist in troubleshooting and resolving minor equipment or process-related issues under the guidance of senior team members.
  • Collaborate with cross-functional teams, including GMP Manufacturing, Quality Assurance, Quality Control, and Product Development, to support efficient manufacturing operations.
  • Assist in equipment setup, inventory management, and material requests for cleaning and manufacturing activities.
  • Contribute to process improvement initiatives, providing feedback and suggestions to enhance department-related processes and improve efficiency.
  • Follow safety procedures and maintain a clean workspace.

Benefits

  • Health, dental and vision insurance start your first day – with 90% of premiums covered for you and your family.
  • A competitive paid time off plan
  • 12 weeks of fully paid parental leave
  • Annual bonus opportunities for all full-time team members.
  • 401(k) with company match
  • Special employee discounts, including childcare and dependent care savings.
  • Onsite fitness facility at The Hearth.
  • Mental health counseling and financial planning services through our Employee Assistance Program.
  • Employer-paid short and long-term disability coverage
  • A fully stocked kitchen with free snacks and beverages
  • Ongoing professional development resources, training, and mentorship programs
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