Manufacturing Calibrations Specialist I

Disability Solutions - Greenville, SC

Full-time - Entry Level

Greenville, SC

Administrative and Support Services

About the position

Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Catalent's Greenville, N.C. facility specializes in end-to-end turn-key solutions for oral solid dosage forms, including integrated formulation development, analytical services, commercial manufacturing, and packaging. This state-of-the-art facility has had over $100M of investments in recent years and features fit-for-scale capacity with potent handling capabilities, ideal for orphan or targeted drug development. The Manufacturing Calibrations Specialist I position is crucial for ensuring that the pharmaceutical manufacturing equipment used to produce oral solid dosage products is properly calibrated and maintained. This role involves performing equipment preventive maintenance and calibration procedures, compiling and maintaining all relevant information and documentation in accordance with FDA guidelines, and working closely with manufacturing operators to schedule calibrations. The specialist will also coordinate repairs and installations with facilities staff, contractors, and users to minimize interruptions in production. Continuous improvement of operations in partnership with manufacturing staff, users, and vendors is a key aspect of this role. The specialist will work from standard operating procedures and will be responsible for entering and tracking calibrations in the BMRAM database, along with any other duties as assigned.

Responsibilities

• Perform equipment preventive maintenance and calibration procedures.
• Compile and maintain all information and documentation relevant to all work in accordance with FDA guidelines.
• Work with manufacturing operators to schedule calibrations.
• Coordinate repairs/installations with facilities staff, contractors, and users to minimize interruptions.
• Partner with manufacturing staff, users, and vendors to continuously improve operations.
• Work from standard operating procedures.
• Enter and track calibrations in BMRAM database.
• Perform all other duties as assigned.

Requirements

• High school diploma required; Associate degree in technical or life sciences discipline preferred.
• 2+ years of pharmaceutical experience is required.
• 3+ years of manufacturing calibration experience preferred.
• Blue Mountain Regulatory Asset Manager experience preferred.
• Good understanding of cGMPs, industry and regulatory standards and guidelines.
• Good understanding of federal and local regulations regarding health and safety within manufacturing and packaging environments.

Nice-to-haves

• Experience with Blue Mountain Regulatory Asset Manager.
• Knowledge of advanced calibration techniques.

Benefits

• Medical, dental, and vision insurance
• 401(k) retirement savings plan with company match
• 152 hours of PTO + 8 paid holidays
• Opportunities for career advancement
• Fast-paced, dynamic environment
• High visibility to members at all levels of the organization.