Equipment Specialist

Job Responsibilities:

• Adhere to production and manufacturing protocols.
• Execute tasks in Grade C, D, and controlled non-classified cleanrooms.
• Conduct aseptic manipulations within Grade A isolators.
• Operate production equipment safely, including setup and changeovers.
• Lead batch startup activities and oversee production cycles, ensuring compliance with validation and engineering protocols as necessary.
• Train team members on various manufacturing processes, including fill/finish, sanitization, and preparation of components and equipment.
• Support equipment optimization and continuous improvement initiatives.
• Address and resolve issues that arise during daily operations, providing prompt solutions.
• Engage in and/or assist with process Failure Modes and Effects Analyses (FMEAs) to assess process and product risks, serving as a prerequisite for process validation.

Qualifications:

• High School diploma with pharmaceutical experience in the installation, operation, cleaning, and maintenance of pharmaceutical GMP equipment.
• In-depth knowledge of pharmaceutical manufacturing for biotechnology products, aseptic processing (fill and finish), and current Good Manufacturing Practices (cGMP).