Equipment Specialist

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.