Industrial Maintenance Technician

1 week ago

Union Valley, Texas, United States Elgen Staffing Full time
Job Overview

Are you ready to contribute to a leading manufacturer in the pharmaceutical sector? We are currently seeking a skilled Maintenance Mechanic to enhance our GMP Fill Finish operations for biologics. In this role, you will play a crucial part in the filtration and filling processes of various pharmaceutical products intended for both clinical and commercial applications.

PRIMARY DUTIES:

  • Complete aseptic qualification training.
  • Demonstrate competencies to Manufacturing Technician I and II.
  • Strictly follow SOPs and product batch record instructions.
  • Maintain comprehensive documentation in compliance with cGMP and GDP standards.
  • Ensure timely documentation in accordance with CGMP regulations.
  • Assist with QC sampling, equipment calibration, and preventive maintenance tasks.
  • Collaborate effectively with internal teams to meet site objectives.
  • Encourage teamwork across departments.
  • Review and uphold accurate documentation.
  • Engage in process enhancement initiatives through Operational Excellence.
  • Set up and dismantle filling equipment as per established procedures.
  • Operate filling machines at validated speeds and volumes.
  • Execute and document necessary interventions.
  • Work alongside R&D and tech transfer teams for program transitions.
  • Aseptically filter products into designated vessels.
  • Conduct routine cleaning and sanitization of controlled environments.
  • Achieve and maintain the capability to perform environmental tasks.
  • Fulfill additional assigned responsibilities.

ESSENTIAL QUALIFICATIONS:

  • High school diploma with 5+ years of relevant experience or a Bachelor's degree with 3+ years of experience.
  • Previous experience in a similar field is advantageous.
  • Ability to work efficiently within a cross-functional team.
  • Basic mathematical skills are required.
  • Experience in cGMP manufacturing and aseptic filling is preferred.
  • Familiarity with Quality Management Systems such as MasterControl.
  • Understanding and adherence to applicable SOPs.
  • Strong knowledge of regulations related to drug production and testing.
  • Proficiency in Microsoft Office applications.
  • Exceptional communication and organizational abilities.
  • Results-driven, energetic, and self-motivated individual.
  • Creative, open-minded, and efficient in managing tasks.
  • Fluent in English with clear handwriting.

Explore this exciting opportunity with Elgen Staffing, a leading staffing agency dedicated to connecting candidates with their ideal roles across various industries.

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