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  • 1 month ago

jobs description

Position Summary:

Catalent Pharma Solutions is Morrisville, NC is hiring a Technical Writer for the Manufacturing and Production Group. The Production department is responsible for the production of Dry Powder Inhalers and Nasal products within Catalent, Morrisville, North Carolina. This includes setup, operation, changeover, and routine maintenance of automated and manual equipment. The... Production department executes, completes, and reviews all associated master batch record documentation; creates and reviews standard operating procedures; creates manufacturing metrics documentation and assists with process development and validation studies. The Technical Writer supports the manufacturing of Phase 1, 2, and 3 for clinical and commercial supplies, working closely with Quality and Operations Management.

This is a full-time role position: Monday – Friday, days.

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. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives.

The Research Triangle Park (RTP) facility is Catalent's Center of Excellence for Analytical Services and is also home to Catalent's Inhalation franchise including product development, clinical and commercial manufacturing for pMDI, DPI and Nasal Sprays.

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 Role
• Perform investigations; write problem reports prior to QA review; write and complete CAPAs, deviations and change controls; interact with customers as needed
• Create and revise standard operating procedures for Production; revisions may be related to process improvements, customer requests and/or audit observations; create and revise procedures for new equipment and batch manufacturing
• Create and revise master batch records including interacting with other departments and customers as necessary; assemble batch related documentation and complete reviews prior to transfer to Quality Assurance; develops proper documentation for batch production
• Interact with Quality Assurance and other functional areas to ensure timely closure of designated batch release investigations; interact with Production personnel on continuous improvement projects related to procedures, batch records, or other assignments; act as coordinator for operations activities including JD Edwards support, batch record requisition, work order completion, and some production planning activities
• Compile and maintain metrics related to operations
• Provide training to management and Production personnel to promote well-written, thorough investigation reports; assist in the training of Operations Technicians.
• Set annual goals with supervisor to improve job and individual skills and abilities; maintain a high level of quality of product and improved established efficiency and yield standards; participate in problem solving teams to resolve mechanical, process, and safety issues
• Assist Engineering to develop manufacturing equipment improvements, quality improvements, and line performance improvements; identify process deficiencies and recommend corrective improvements
• All other duties as assigned;

The Candidate
• Associates degree required, Bachelors degree preferred
• 3 or more years of related experience required with a Bachelors degree; 5 or more years of experience required with an Associates degree
• Relevant experience working with Dry Powder Inhalation and Nasal Processes is required
• Background in Quality is preferred
• Experience writing deviations, investigations, CAPAs, and change controls is preferred
• Experience rewriting and revising batch records is preferred
• Strong written and verbal communication skills required
• Ability to read, understand, and interpret technical instructions is required
• Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds;

Why you should join Catalent:
• Defined career path and annual performance review and feedback process
• Diverse, inclusive culture
• 152 hours of PTO + 8 paid holidays
• Several Employee Resource Groups focusing on D&I
• Dynamic, fast-paced work environment
• * Positive working environment focusing on continually improving processes to remain innovative
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
• Competitive salary with bonus potential
• Community engagement and green initiatives
• Generous 401K match and Paid Time Off accrual
• Medical, dental and vision benefits effective day one of employment
• Tuition Reimbursement – Let us help you finish your degree or earn a new one!
• GymPass program to promote overall physical wellness
• Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories

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.

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

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
Morrisville NC USA

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