Process Operator

Catalent • Malvern, PA

2d • Onsite

About The Position

Process Operator Position Summary 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. The Process Operator micronize\mills client provided material including both active pharmaceutical ingredients and excipients as per Catalent Micron Technologies procedures and policies, client instructions and cGMP guidelines. The Process Operator will consistently model Catalent values and leadership behaviors in all interactions. This position is 100% on-site at the Malvern site. Shift: Monday - Thursday 1 pm - 11:30 pm The Role Micronization and milling of both hazardous and non-hazardous pharmaceutical actives and excipients. Set up, operate equipment, and monitor production processes and report production on batch records in accordance with good documentation procedures (GDPs). Review documentation (batch records, SOPs, Logbooks) for completeness, clarity, accuracy and submit edits to documents for revision as required. Capable of reading and following defined SOPs and policies and executes tasks accordingly. Work in accordance with cGMP. Identify and communicate non-routine events, deviations and GMP deficiencies to supervisor in a timely manner. Produce thorough, clear & consistence documentation in compliance with Quality Standards (Attributable, Legible, Contemporaneous, Original and Accurate). Participate in shift change meetings, site/team meetings, sending/receiving emails, offering suggestions for improvements, and participating in projects. All other duties as assigned.

Requirements

• Requires High School Diploma or GED
• Personal protective equipment, including gloves, a respirator hood, safety glasses, safety shoes and other Personal Protective Equipment is provided and is required to be worn in designated areas.
• Physical strength, stamina and dexterity while wearing fully enclosed air suite.
• Required to work safely with high potency active pharmaceutical ingredients (HPAPI) as well as novel compounds of unknown potency and toxicity.
• Ability to perform moderate physical labor including: lifting, climbing, bending, crouching, reaching and twisting, stand or walk for up to 8 hours per day, climb steps/ladders and occasionally work from elevated platforms, wear a respirator hood and pass the required respiratory medical exam.
• Employees be able to lift or move items up to 44 lbs. (20kg) individually, or with a two-person lift between 45 lbs and 76 lbs. (35kg). 77 lbs and over with a lift assistance device.
• Ability to work in loud environments and wear various types of hearing protection

Nice To Haves

• Prior manufacturing experience and work in a regulated environment preferred.
• Prior Production Experience preferred.

Responsibilities

• Micronization and milling of both hazardous and non-hazardous pharmaceutical actives and excipients.
• Set up, operate equipment, and monitor production processes and report production on batch records in accordance with good documentation procedures (GDPs).
• Review documentation (batch records, SOPs, Logbooks) for completeness, clarity, accuracy and submit edits to documents for revision as required.
• Capable of reading and following defined SOPs and policies and executes tasks accordingly.
• Work in accordance with cGMP.
• Identify and communicate non-routine events, deviations and GMP deficiencies to supervisor in a timely manner.
• Produce thorough, clear & consistence documentation in compliance with Quality Standards (Attributable, Legible, Contemporaneous, Original and Accurate).
• Participate in shift change meetings, site/team meetings, sending/receiving emails, offering suggestions for improvements, and participating in projects.
• All other duties as assigned.

Benefits

• Competitive medical benefits and 401K
• 152 hours of PTO + 8 Paid Holidays
• Dynamic, fast-paced work environment
• Opportunity to work on Continuous Improvement Processes
• Catalent offers rewarding opportunities to further your career!
• Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world.
• Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market.
• Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED
• Number of Employees: 5,001-10,000 employees