LIMS Specialist

King of Prussia, PA
Full Time
Information Technology
Mid Level
Position Summary:

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.

SK pharmteco, Cell and Gene US is seeking a dynamic LIMS Specialist to join our IT team. The LIMS Specialist will be part of a team that provides key support for a LabWare LIMS system. The role will assist in the deployment of projects that add new processes or enhance functionality in the system. The role will participate in the validation of such project by generating, executing, and reviewing qualification protocols. This role will also support integration to other systems.
The role will ensure the system adheres to cGxP guidelines and regulations. This role will work closely with users from other business units to identify opportunities for process improvement, provide training and demonstrations, and troubleshoot issues experienced by end users.
The role will require leading system-related investigations, change controls, corrective and preventative actions as part of the site Quality programs.
*This is a full-time onsite role based in King of Prussia, PA.

Primary Responsibilities:
  • Understands and supports all GMP, safety, and environmental regulations.
  • Develop new tools to increase capability and efficiency of system processes.
  • Troubleshoot issues and implement solutions to prevent recurrence.
  • Participate in approval cycles for testing protocols and sample plans to review their compatibility with system configuration
  • Participate in and help develop training programs for onboarding new system users and releasing new functionality.
  • Draft, review, and/or execute validation protocols.
  • Collaborate with multi-functional teams to ensure seamless integration of IT solutions.
  • Facilitate data entry, storage, and reporting.
  • Maintain and regularly update master data.
  • Maintain technical and quality documentation.
  • Additional duties as assigned.
Education & Experience:
  • Bachelor’s degree in Engineering (Chemical, Electrical, Mechanical, etc.), Science or Information Technology or related field. 
  • 2-5 years’ experience with LIMS or LIMS Administration
  • Effective interpersonal and communication skills (written and oral).
  • Familiarity with SQL and Visual Basic scripting is preferred.
  • Excellent verbal and written communication skills.
  • Strong analytical and problem-solving skills.
Physical Requirements:
  • Ability to sit for periods of time viewing a computer workstation.


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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