Manufacturing Support I

Apex Systems
Published
July 15, 2021
Location
Horsham, PA
Category
Job Type

Description

Apex Systems is seeking Manufacturing Support Associates for one of our Bio-Pharmaceutical clients located near Willow Grove, PA. The ideal candidate will have 1-2  years+ of experience in a GMP environment.

Job Summary:

The Manufacturing Associate I, Manufacturing Support Services works in a hands-on capacity in the cGMP production support areas (buffer preparation, equipment cleaning, etc.) to support manufacture of bulk drug substance (BDS). This role is responsible for supporting necessary production and production-related activities, including validation and development work as needed. 

Responsibilities:

  • Performs daily weigh/dispense, buffer preparation, and other process support operations for cGMP manufacture of CCH BDS.
  • Works in a hands-on capacity to prepare buffers for purification and fermentation production steps as per manufacturing schedules.
  • Enters/updates data into compliance documents and computer applications.
  • Assists with and executes process, equipment, and cleaning validation protocols.
  • Assists in the resolution of manufacturing deviations/non-conformances.
  • Assists with troubleshooting processes and equipment.

Education and Experience:

  • High school diploma is required with a minimum of 0-3  years working in biopharmaceutical cGMP commercial or late-stage clinical manufacturing environment, or equivalent relevant experience.

Knowledge:

  • General knowledge of cGMP practices, ICH guidelines, and validation practices.
  • General knowledge of chromatographic and UF/DF principles.

Skills and Abilities:

  • Ability to follow schedules and work plans, and coordinate with manufacturing groups to provide timely support.
  • Ability to work well with others and establish working relationships with Quality, Facilities/Engineering/Validation, Process Validation/Development, and Manufacturing.
  • Exhibits attention to detail, accuracy in work, and integrity of character.
  • Self-starter, shows willingness to learn and problem-solve.
  • Has technical aptitude to learn and operate production equipment.

Physical Requirements:

  • Ability to stand for long periods of time.
  • Ability to wear a sterile gown and shoe covers on a daily basis.
  • Ability to lift 40 pounds.

For immediate consideration, please email a copy of your resume to [Click Here to Email Your Resumé]

EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178

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