Suite Sanitation Manufacturing - Support Services Associate I

Minaris•Philadelphia, PA

12d•Onsite

About The Position

Responsible for the support activities and disinfection of 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).

Requirements

Must be able to wear appropriate clean room attire (i.e. surgical masks) and all Personal Protective Equipment (PPE).
Possesses basic technical knowledge and background
Understands aseptic technique concepts/proper cleanroom behavior
Possess basic computer skills and able to efficiently use basic Microsoft applications
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
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.
Proficient in Oral & Written communication skills
Need to be able to read, write and understand English
Proficient in Microsoft (Excel, Word, Outlook)
High School diploma or equivalent
1-2 years of relevant or equivalent experience
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.
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

Nice To Haves

May be required to work holidays and weekends
May be required to work overtime
May be required to work outside of normal business hours
Thorough understanding of Good Laboratory Practices and Good Manufacturing Practices
Other duties as assigned
Employee may travel by car and airplane to work at different locations and may occasionally be required to travel overnight.

Responsibilities

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
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
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
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.
May be required to assist in other departments