Process Operator

Catalent • Malvern, PA

1d • 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.
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.

Requirements

• High school diploma or GED required.
• 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).
• Ability to perform moderate physical labor (lifting, climbing, bending, crouching, reaching, twisting) with the strength and stamina to handle materials up to 44 lbs independently (greater weights with assistance), stand or walk up to 8 hours, work on ladders/elevated platforms, and safely operate in loud, hazardous environments involving HPAPI or unknown compounds while consistently wearing required PPE (including respirator hood) and meeting all safety and medical clearance requirements.

Nice To Haves

• Prior Production Experience preferred
• 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.

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.

Benefits

• Defined career path and annual performance review and feedback process
• Diverse, inclusive culture
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
• 152 hours of paid time off annually + 8 paid holidays
• Competitive salary with yearly bonus potential
• Community engagement and green initiatives
• Generous 401K match and Paid Time Off accrual
• Medical, dental and vision benefits effective day one of employment
• Tuition Reimbursement

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED