Process Operator I
Process Operator I
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1 Vacancy
Job Description
Process Operator I
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 lifecycle supply. With timetested experience in development sciences delivery technologies and multimodality 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 lifeenhancing and lifesaving treatments for patients annually.
The Process Operator micronizemills 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 I will consistently model Catalent values and leadership behaviors in all interactions.
Shift: Monday Thursday 1 pm 11:30 pm
The Role
Micronization and milling of both hazardous and nonhazardous 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 nonroutine 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.
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 heath & 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 twoperson 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
Fastpaced Performance Driven PatientFocused 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 fastpaced 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 7000 lifesaving and lifeenhancing 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.
Visit Catalent Careers to explore career opportunities.
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 . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
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. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
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 for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE.
Employment Type
Full-Time
