Process Operator at CATALENT CTS SINGAPORE PRIVATE LIMITED

Malvern, Pennsylvania, United States -

Full Time

Start Date

Immediate

Expiry Date

05 Apr, 26

Salary

0.0

Posted On

05 Jan, 26

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Micronization, Milling, Production Processes, Documentation, SOPs, cGMP, Quality Standards, Physical Labor, Safety Procedures, Team Meetings, Communication, Problem Solving, Attention to Detail, Equipment Operation, Hazardous Materials Handling, Continuous Improvement

Industry

Pharmaceutical Manufacturing

Description

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. The Candidate Requires High School Diploma or GED Prior manufacturing experience and work in a regulated environment preferred. 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. 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. 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. 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 DisabilityAccommodations@catalent.com. 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 spam@catalent.com for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE. 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.

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Responsibilities

The Process Operator is responsible for micronizing and milling pharmaceutical materials according to established procedures and guidelines. They will monitor production processes, maintain documentation, and communicate any deviations or issues to supervisors.