Technical Writer

Technical Writer

Position Summary:

• Work Schedule:Monday - Friday 8:00am to 4:30pm
• 100% on-site

The Morrisville (MSV) facility is Catalents center of excellence for nasal product development and manufacturing providing endtoend services from early formulation through clinical and commercial production. The site offers comprehensive nasal development capabilities including analytical support device selection spray characterization and both clinical and commercial scale for unitdose bidose and multidose nasal products. The Morrisville site also provides development services for dry powder (DPI) and liquid pulmonary products including formulation development and optimization methodservicesand analytical testing.

The Technical Writer supports the manufacture of Phase 1 2 and 3 for clinical supplies and commercial supplies working closely with quality and operations management.

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
• 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
• 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
• Other duties as assigned

The Candidate:

• Must have Bachelors Degree and minimum of 1 year related experience OR
• Associates Degree and minimum of 3 years related experience OR
• Equivalent combination of relevant education experience and training will be considered in lieu of Associates and Bachelors degree.
• Must have proficiency in MS Office
• Ability to read understand and interpret technical instructions and technical writing is required
• Previous clinical and commercial operations experience is preferred
• Prior direct experience with manufacturing operations - Cleaning Compounding
  Filling Inspection and Assembly Operations is preferred

Why you should join Catalent:

• Defined career path and annual performance review and feedback process
• Diverse inclusive culture
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
• 152 hours of PTO 8 paid holidays
• Generous 401K match
• Medical dental and vision benefits
• Tuition Reimbursement- Let us help you finish your degree or start a new degree!

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7000 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 . 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.

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