Process Operator

Catalent Pharma Solutions•Malvern, PA

13d•Onsite

About The Position

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee. The Process Operator micronize\mills client provided material including both active pharmaceutical ingredients and excipients as per Catalent Malvern procedures and policies, client instructions and cGMP guidelines. Consistently models Catalent values and leadership behaviors in all interactions.

Requirements

High school diploma or GED required.
Strong organizational, detail-oriented, and multitasking abilities with effective prioritization and solid basic math/interpretation skills.
Clear oral and written communication skills with a willingness to learn, adapt to change, and work with new processes.
Ability to work safely in environments with potential exposure to hazardous chemicals, consistently using required PPE (e.g., gloves, respirator hood, safety glasses, safety shoes).

Nice To Haves

Prior Production Experience preferred

Responsibilities

Perform entry-level micronization and milling of hazardous and non-hazardous pharmaceutical actives and excipients while following defined procedures.
Set up, operate, and monitor production equipment and processes to ensure safe and efficient operations.
Complete batch records and documentation in compliance with GDP and ALCOA principles, ensuring accuracy and consistency.
Maintain strict adherence to cGMP standards, SOPs, and regulatory policies in a controlled environment.
Identify, report, and escalate deviations, non-routine events, and GMP deficiencies in a timely manner.
Clean and maintain processing equipment and production areas to meet quality and compliance standards.
Participate in team communications, including shift handovers, meetings, and continuous improvement initiatives.
Demonstrate a proactive mindset by asking questions, adapting to change, supporting new processes, and driving First Time Right (FTR) performance.
Other duties as assigned.