Technical Writer

Disability Solutions - Morrisville, NC

Full-time - Mid Level

Morrisville, NC

Administrative and Support Services

About the position

Catalent Pharma Solutions is seeking a Technical Writer for the Manufacturing and Production Group at our Morrisville, NC facility. This role is integral to the production of Dry Powder Inhalers and Nasal products, which involves the setup, operation, changeover, and routine maintenance of both automated and manual equipment. The Technical Writer will be responsible for executing, completing, and reviewing all associated master batch record documentation, creating and reviewing standard operating procedures, and assisting with process development and validation studies. This position supports the manufacturing of clinical and commercial supplies for Phase 1, 2, and 3, working closely with Quality and Operations Management. As a full-time position, the Technical Writer will work Monday through Friday during the day. Catalent is a global, high-growth public company and a leading partner in the pharmaceutical industry, dedicated to developing and manufacturing new treatments for patients worldwide. The Research Triangle Park (RTP) facility serves as Catalent's Center of Excellence for Analytical Services and is home to the Inhalation franchise, which includes product development and clinical and commercial manufacturing for pMDI, DPI, and Nasal Sprays. Catalent is committed to a Patient First culture, emphasizing excellence in quality and compliance, and prioritizing the safety of every patient, consumer, and employee. In this role, the Technical Writer will perform investigations, write problem reports prior to QA review, and complete CAPAs, deviations, and change controls. They will interact with customers as needed and create and revise standard operating procedures for Production, which may involve process improvements, customer requests, and audit observations. The Technical Writer will also create and revise master batch records, ensuring proper documentation for batch production and timely closure of designated batch release investigations. Additionally, they will compile and maintain metrics related to operations and provide training to management and Production personnel to promote well-written, thorough investigation reports. The role also includes assisting Engineering in developing manufacturing equipment improvements and identifying process deficiencies to recommend corrective actions. Other duties may be assigned as necessary.

Responsibilities

• Perform investigations and 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.
• Create and revise master batch records, interacting with other departments and customers as necessary.
• Assemble batch-related documentation and complete reviews prior to transfer to Quality Assurance.
• Develop proper documentation for batch production.
• Interact with Quality Assurance and other functional areas to ensure timely closure of designated batch release investigations.
• 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.
• Perform all other duties as assigned.

Requirements

• Associates degree required, Bachelor's degree preferred.
• 3 or more years of related experience required with a Bachelor's 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.

Nice-to-haves

• Experience in a pharmaceutical manufacturing environment.
• Familiarity with regulatory compliance standards in the pharmaceutical industry.

Benefits

• 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 to help finish or earn a new degree.
• GymPass program to promote overall physical wellness.
• Perkspot offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories.