Job Description

Process Operator

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 micronizes/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.
• Ability to work in a regulated environment with adherence to standard operating procedures.
• 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 & consistent 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.

The Candidate

• High School Diploma or GED.
• Must be dependable, ready/eager to learn and able to meet the physical requirements of the job.
• Prior manufacturing experience and work in a regulated environment preferred.
• Ability to work weekday and weekend OT a plus.
• Organizational Skills, Detail Orientation, Communication Skills Oral and Written, Basic Math Skills, interpretation.
• Potential limited exposure to health & physically hazardous chemicals.
• 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.
• Prior Production Experience preferred.
• Physical strength, stamina and dexterity while wearing fully enclosed air suite.
• 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.
• 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.
• Ability to work in loud environments and wear various types of hearing protection.
• Ability to work with chemicals, health/physical hazardous material safely and in compliance with the site safety program.
• Fast-paced, Performance Driven, Patient-Focused, Collaborative and inclusive, Professional Office Setting, Confidential Department.
• To perform this job successfully, an individual must be able to perform each duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Why You Should Join Catalent

• 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. Join us in making a difference.

Personal initiative. Dynamic pace. Meaningful work.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent.

Important Security Notice to U.S. Job Seekers:

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE.

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