Production Support Specialist

2 weeks ago


King of Prussia, Pennsylvania, United States SK pharmteco Full time

Position: Manufacturing Support Services Associate (2nd Shift)

Location: King of Prussia

Company: SK Pharmteco

The Manufacturing Support Services Associate I or II is tasked with executing routine cleaning and assembly functions that facilitate the production of gene therapies. This role involves supporting the creation of viral vectors, non-viral vectors, and advanced therapeutics while ensuring adherence to cGMP standards.

Key Responsibilities:

  • Engage in hands-on activities to prepare buffers, assemble jumper harnesses, and clean/sterilize equipment and materials.
  • Collaborate closely with manufacturing teams by transferring and stocking essential materials and delivering samples throughout the facility.
  • Maintain cleanliness in GMP areas, collect waste from production suites, and execute decontamination protocols.
  • Contribute to the maintenance of the cGMP status of the manufacturing facility to ensure readiness for inspections. Ensure that all tasks are performed in compliance with approved SOPs, batch records, controlled documentation, and all relevant regulations, guidelines, safety policies, and procedures.
  • Assist in addressing manufacturing support deviations and non-conformances.
  • Support validation activities related to the qualification of manufacturing support equipment.

Qualifications:

  • A high school diploma is required; a bachelor's degree in biological sciences or a related engineering field is preferred.
  • 0-2 years of experience in cGMP biological manufacturing is required, with preference given to candidates with Contract Development and Manufacturing Organization (CDMO) experience. General knowledge of cGMP regulations is essential.
  • Experience working in a Biological Safety Cabinet (BSC) is advantageous. Ability to work independently and collaboratively within a team is necessary.
  • Demonstrated attention to detail, accuracy in work, and integrity of character. A self-starter with a willingness to learn and solve problems is essential.
  • Willingness to learn and operate production equipment, while adhering to all safety and company regulations.
  • Flexibility to accommodate a varied work schedule to meet business needs.

Core Competencies:

  • Strong verbal and written communication skills.
  • Excellent interpersonal and customer service abilities.
  • Outstanding organizational skills and meticulous attention to detail.
  • Effective time management skills with a proven ability to meet deadlines.
  • Robust analytical and problem-solving capabilities.
  • Leadership and supervisory skills.
  • Ability to prioritize tasks and delegate appropriately.
  • Capacity to thrive in a fast-paced and occasionally stressful environment.

Physical Requirements:

  • Extended periods of sitting at a desk and working on a computer.
  • Ability to lift up to 15 pounds occasionally.


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