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Equipment Specialist

Indianapolis $35 - $40/HR Permanent

Job Title:
Equipment Specialist - 3rd Shift

Job Overview:
The Equipment Specialist is a key technical role within pharmaceutical operations, responsible for setting up, operating, and maintaining production equipment in a GMP-regulated environment. This position requires hands-on involvement with aseptic processing, equipment troubleshooting, and continuous process improvement. The ideal candidate will bring strong mechanical aptitude, problem-solving skills, and leadership abilities to support safe, efficient, and high-quality manufacturing activities on the 3rd shift.

Job Responsibilities:

  • Follow established production and manufacturing procedures in compliance with GMP requirements.

  • Perform duties in Grade C, D, and controlled non-classified cleanrooms.

  • Conduct aseptic manipulations within Grade A isolators.

  • Safely operate production equipment, including setup and changeovers.

  • Lead batch start-up activities and oversee execution of production cycles.

  • Accurately complete batch records and related documentation.

  • Execute validation and engineering protocols as assigned.

  • Train team members on tasks such as fill/finish, sanitization, and equipment preparation.

  • Maintain and troubleshoot production equipment to ensure reliable performance.

  • Support equipment optimization and continuous improvement initiatives.

  • Provide timely technical support and resolution of daily operational issues.

  • Serve as a subject matter expert for filling equipment and supporting systems.

  • Participate in process FMEAs to identify and mitigate product and process risks.

  • Apply Good Engineering Practices (GEP) to enhance engineering and operational excellence.

  • Work flexible hours as needed to maintain production coverage.

Qualifications:

  • High school diploma with a minimum of 7 years of GMP pharmaceutical experience in equipment installation, operation, cleaning, and maintenance.

  • Previous experience with aseptic processing (fill/finish) in a GMP environment.

  • Proficiency in MS Office applications including Word and Excel.

  • Strong mechanical aptitude with proven troubleshooting skills.

  • Excellent written and verbal communication skills.

  • Ability to apply mathematical concepts such as ratios, percentages, and proportions in practical applications.

  • Ability to learn and operate ERP and inventory management systems.

  • Bachelor’s degree in biological sciences, biotechnology, or related field with at least 1 year of GMP pharmaceutical experience preferred.

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