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Technical Writer

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.

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 Technical Writer is responsible for collecting, organizing, formatting and authoring documents. The Technical Writer will make inputs into the site inventory management system for Manufacturing activities.

This position is 100% on-site at the Greenville site.

The Role

+ Work with Subject Matter Expert (SME) to gather the information needed to create new Technical Services documents or updates of existing documents (i.e. Master Batch Records and protocols) and coordinate associated change control documents.

+ Review documents with SME and Operations personnel to ensure they are accurate, executable and the formatting is consistent and harmonized.

+ Ensure the documentation database is accurate and inputs conform to company standards.

+ Ensure and assist in making inputs to the Manufacturing Resource Planning in preparation for Technical Services manufacturing events.

+ Responsible to close out Technical Service help desk tickets regarding Technical Service document corrections and updates.

+ Provide requested information during client and FDA audits.

+ Participate and contribute to the activities of the cross functional project development teams.

+ Participate and contribute to the continued implementation of electronic document software system.

+ All other duties as assigned.

The Candidate

+ Bachelor’s degree in a Science-related field, Engineering or Industrial Technologies with at least 1 year of relevant experience preferred; previous technical writing experience preferred or;

+ Associate degree in a Science-related field, Engineering or Industrial Technologies with at least 2 years of relevant experience preferred; previous technical writing experience preferred or;

+ High school diploma or equivalent with at least 3 years of relevant industry experience; previous technical report writing preferred.

+ Ability to administer quality system programs and resources.

+ Familiar with GMP documentation requirements.

+ Experience with database management software.

+ Position requires the ability to occasionally lift 40 lbs unassisted, and occasionally push and pull a maximum of 100 lbs.

+ Majority of workday is performed while sitting, standing, and walking.

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

+ Ability to climb, bend, stoop, twist, and have full range of motion in upper and lower extremities.

+ Occasional exposure to dust, fumes, gases, skin and respiratory irritants, moving machinery parts, and damp, humid and wet environments.

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 (https://careers.catalent.com/us/en) 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 [email protected] . 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 [email protected] for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .