Technician I, GMP Manufacturing Support - Sanitization (1st Shift)

About the Role

The Technician I, GMP Manufacturing Support, performs a wide range of functions crucial to AAV gene therapy production. This entry-level position offers an opportunity to gain foundational experience in the multifaceted support activities essential for the production of AAV gene therapy products.

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.

Qualifications

• 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.

Preferred Skills

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

Work Environment and Physical Demands

This position works in both a laboratory environment and typical office environment where the physical work demands will vary depending on the specific tasks and duties required of the job. The employee will be stationary (standing/sitting) for extended periods of time. Employees regularly wear personal protective equipment based on the task being performed. Must be able to work in a confined space, such as a clean room or laboratory environment. Ability to identify small details within the field of vision, distinguish between different colors, and accurately identify objects within a specific area.

Benefits

• Health, dental, and vision insurance starting your first day, with 90% of premiums covered for you and your family.
• 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.
• Fully stocked kitchen with free snacks and beverages.
• Ongoing professional development resources, training, and mentorship programs.