Suite Sanitation Manufacturing - Support Services Associate I

Be part of something bigger at Minaris Advanced Therapies-where every role contributes to creating hope for patients around the world. As a global leader in cell and gene therapy development, manufacturing, and testing, we turn breakthrough science into real-world treatments that change lives. Our team of over 1,000 experts across North America, Europe, and Asia has helped bring transformative therapies to market.

At Minaris, you'll join a purpose-driven community focused on innovation, collaboration, and patient impact. Whether you're in the lab, in the cleanroom, or behind the scenes, your work will directly support life-saving therapies and make a lasting difference. If you're passionate about advancing cutting-edge science and believe in the potential of cell and gene therapies, we invite you to help shape the future of medicine-one patient at a time.

Position Summary

Responsible for the support tasks to sanitize and disinfect GMP space, equipment and associated areas involved in the manufacture of Master and Working Cell Banks, within production facilities involved in the manufacture Cell & Gene Therapy products and final product fills according to current Good Manufacturing Practices (cGMPs).

This is not an administrative job. Working hours are 4:00pm - 2:30am.

Essential Functions and Responsibilities

• Must be able to wear appropriate clean room attire (i.e. surgical masks) and all Personal Protective Equipment (PPE)
• Perform cleaning methods, such as wiping techniques of equipment, wall and ceiling and floor mopping techniques.
• Responsible for the operation, maintenance and cleaning of equipment
• Responsible for the cleaning/sanitization solution and material preparation
• Possesses basic technical knowledge and background
• Understands aseptic technique concepts/proper cleanroom behavior
• Responsible for receiving and organizing gowning and cleaning materials

Identifies and communicates material discrepancies

• Follows compliance and regulatory requirements and current Good Manufacturing Practices (cGMPs)
• Follows and executes Standard Operating Procedures (SOPs)
• May participate in the training activities of others on SOPs, equipment, all unit operations and non-manufacturing SOPs
• May participate in the training activities of others on basic operations such as cleaning/sanitization of cleanrooms, cleaning and maintenance of equipment, solution and material preparation
• Participates with technical documents such as non-conforming events and deviations
• Possess basic computer skills and able to efficiently use basic Microsoft applications
• Suggests continuous improvement ideas

• Follow Proper cleaning/disinfecting schedules
• Assist Supervision with internal pre-audits walkthroughs, CGMP housekeeping and general organization and upkeep of manufacturing spaces

• Maybe required to work holidays and weekends
• May be required to work overtime
• May be required to work outside of normal business hours
• Contributes to the overall operations and to the achievement of departmental goals
• Perform job specific tasks in compliance with applicable Regulations, International Standards, and Minaris Advanced Therapies Policies and Standard Operating Procedures.

• Thorough understanding of Good Laboratory Practices and Good Manufacturing Practices
• Other duties as assigned
• May be required to assist in other departments

Knowledge, Skills & Ability

• Thorough understanding of regulatory requirements for cGMP manufacturing facility, especially as they apply to cleaning practices/sterility assurance.
• Ability to accurately and reproducibly perform arithmetic calculations including fractions, decimals and percentages and basic algebraic and geometric calculations

• Must be able to wear appropriate clean room attire (i.e. surgical masks) and all Personal Protective Equipment (PPE).
• Works in production environment with exposure to latex and bleach. Potential exposure to noise and equipment hazards (i.e. vacuum pumps, pressurized vessels), dangerous materials (i.e. chemicals, solvents, pathogens), freezer burns, allergens and strong odors.
• Based on work assignments, it may be recommended to have medical testing in accordance with the company's Occupational Health Program.
• Holiday and shift work are often required based on manufacturing schedule as determined by Management.
• Proficient in Oral & Written communication skills

• Need to be able to read, write and understand English
• Proficient in Microsoft (Excel, Word, Outlook)

Education & Experience

• High School diploma or equivalent
• 1-2 years of relevant or equivalent experience

Quality Requirements (required field - do not edit)

• Ensure compliance with all FDA and Worldwide Quality & Compliance regulations in all aspects of your work.
• Adhere to established procedures and protocols, prioritize continuous training and skill development, and uphold the highest standards of data integrity to ensure accuracy, compliance, and operational excellence.

Working Environment

Onsite Employees: Employee will work with moderate noise level. Employee will perform tasks while experiencing numerous interruptions. Employee may travel by car and airplane to work at different locations and may occasionally be required to travel overnight. The work environment is fast paced. This position has the utmost responsibility for compliance with the rules and regulations regarding a safe and healthy work environment relative to their actions and conduct. Off-shift, weekend and overtime duties may be required. While performing the job duties of this job, the employee is regularly required to use English written and oral communication skills.

Physical Requirements

• Must be able to work in Lab Setting with Biohazards/Various Chemicals
• Must be able to work in an office environment with minimal noise conditions
• Must be able to wear appropriate PPE
• Must be able to work in clean room environment
• Must be able to work in various noise levels
• Ability to stand/sit/walk for long periods of time
• Ability to lift, push, pull 40 lbs. routinely, often/occasionally
• Ability to crouch, bend, twist and reach
• Clarity of Vision
• Ability to identify and distinguish colors
• Must be able to perform activities with repetitive motions
• Inside/outside working conditions
• Ability to work in variable temperatures high to freezing
• Ability to climb Ladders / Stairs / Scaffolding

Disclaimer

The above information in this description is intended to describe the general nature and level of work performed. It does not contain nor is it intended to be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job. Duties, responsibilities, and activities may change at any time with or without notice.

Minaris Advanced Therapies employees are eligible for a comprehensive benefits package, including medical insurance, vision insurance, dental insurance, 401(k), paid time off, tuition assistance, and more.