Manufacturing Cleanroom Support Associate

King of Prussia, PA
Full Time
Manufacturing
Entry Level
Company Overview:
SK pharmteco (SKPT, the Corporation) is a U.S.-based global Contract Development and Manufacturing Organization (CDMO) that consolidates the operations of sites worldwide – Korea, France, Ireland, and the United States (CA and PA).  Built on over 75 years of experience, SK pharmteco is a trusted partner specializing in the manufacture of small molecule APIs and intermediates, viral vectors for gene therapies, cell therapies, registered starting materials and analytical services for the pharmaceutical industry worldwide.

Position Summary:
The Manufacturing Cleanroom Support Associate is a detail-oriented and reliable Cleanroom Support Associate that supports the sanitization of the manufacturing cleanroom environment.  The Associate is responsible for executing the cleaning of the manufacturing facility and all support activities while maintaining compliance to cGMP standards.
This role is essential to maintaining compliance with regulatory standards (e.g., GMP, ISO) and ensuring a safe and contamination-free production area.  This requires individuals that are willing to work within a team, are hard-working, and highly motivated. This position requires multi-tasking and excellent peer-to-peer communication skills. 
The planned schedule for this position will be second shift, Sunday through Thursday, including holidays. There will be a need at times to support Fridays and Saturdays based on manufacturing process demands.

Primary Responsibilities:
  • Understand concepts of aseptic clean room behavior.
  • Follows and understands GMPs.
  • Ensures all work is completed in compliance with SOPs and safety policies.
  • Revises and authors SOPs, as required.
  • Gown appropriately based on the governing SOP for that working area up to and including Grade B / Aseptic manufacturing suites.
  • Perform scheduled cleaning and disinfection of cleanroom and lab areas including floors, walls, ceilings, equipment surfaces, and airlocks in accordance with cleaning SOPs.
  • Handle and prepare cleaning agents and disinfectants according to established safety guidelines and SOPs.
  • Stocking of materials and gowning supplies.
  • Responsible to maintain inventory accuracy for supplies within areas assigned, this includes Enterprise Resource Planning (ERP) training for computer transactions via SAP.
  • Document all cleaning activities in logbooks and checklists accurately and in real-time.
  • Monitor supply levels of cleaning materials and notify area management when replenishment is needed.
  • Additional project-based activities aligned with improving organizational, functional, and/or compliance of manufacturing suites at the site.
  • Assist in cleanroom inspections and audits by providing documentation and ensuring compliance.
  • Additional responsibilities as needed.
Education & Experience:
  • H.S/Assoc Degree, or B.S (science preferred) is preferred.
  • General knowledge of cGMP regulations.
  • Ability to work well independently and as part of a team.
  • Exhibits attention to detail, accuracy in work, and integrity of character.
  • Self-starter who shows willingness to learn and problem-solve.
  • Able to adhere to all safety and company regulations.
  • Able to accommodate a flexible work schedule to support business demands.
Physical Requirements:
  • Ability to carry up to 55 pounds.
  • Ability to stand for long periods of time while wearing cleanroom gowning and PPE daily.
  • The planned schedule for this position will be second shift, Sunday through Thursday including holidays. There will be a need at times to support Fridays and Saturdays based on manufacturing process demands.

Note: This job description is intended to convey information essential to understanding the scope of the job role. It is not intended to be an exhaustive list of qualifications, responsibilities, and skills required. Additional duties may be assigned as necessary.

SK pharmteco Inc., is an equal opportunity employer who prohibits discrimination and harassment of any type, and affords equal employment opportunities to employees and applicants.
 
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