Pharmaceutical Operator II

1 day ago

Greenville, United States Disability Solutions Full time

Pharmaceutical Operator II

Position Summary

Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Catalent’s Greenville, N.C. facility specializes in end-to-end turn-key solutions for oral solid dosage forms, including integrated formulation development, analytical services, commercial manufacturing, and packaging. This state-of-the-art facility has had over $100M of investments in recent years and features fit-for-scale capacity with potent handling capabilities, ideal for orphan or targeted drug development. 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 Pharmaceutical Operator II will assist and support formulation and process development activities in Development, Pre-Commercial, and Scale-Up Manufacturing Areas. With some supervision, the Pharmaceutical Operator II will assist in developing and optimizing suitable formulations, processes, manufacture of development, stability, and CTM batches.

The Role

  • With some supervision, assist with the writing of SOP’s, IQ/OQ/PQ documents, development/technical reports, and CMC sections for regulatory submissions as directed.

  • Ensure that all work is accurate, precise, properly documented and in the case of CTM’s and commercial product, performed within GMP guidelines.

  • With some supervision, support and assist in qualification of facility and equipment.

  • Working with inventory control personnel, help ensure that an adequate inventory of raw materials is maintained at all times.

  • Maintain competence and training documentation for relevant equipment and processes.

  • Perform any additional assigned tasks including: calibration, analysis, cleaning, facility maintenance, raw material inventory, warehouse operations, etc.

  • Ensure  integrity  of  data  through  accurate  transactions,  documentation,  and  tracking  of  all  cGMP  activities  in  the development group.

  • Assist  development staff in activities related  to  the  development and optimization of suitable formulations and processes, stability, and GMP batches.

  • All other duties as assigned.

The Candidate

  • Bachelor’s degree in Chemistry, Engineering or related science OR;

  • Associate’s degree in Applied Science with four years of equivalent pharmaceutical industry experience OR;

  • High school diploma or equivalent with six years of equivalent pharmaceutical industry experience.

  • Position requires the ability to lift in excess of 50 lbs unassisted.

  • Majority of work day is performed while standing, walking, lifting, pulling, pushing.

  • Requires the use of hands for simple grasping and fine manipulations.

  • Requires bending, squatting, reaching, pushing, climbing.

  • Requires the ability to stand for extended periods of time.

  • Some exposure to hazardous chemical and other active chemical ingredients.

  • Must be able to use a variety of tools, equipment, and machinery.

  • This position requires that a respirator be worn for your safety, and as such, employment is contingent upon being able to complete a medical evaluation with satisfactory results. The medical evaluation is conducted via an external vendor assigned by Catalent.

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.

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