Catalent Pharma Solutions Sr. Technical Writer in St. Petersburg, Florida

Job Description

The Senior Technical Writer reports to the Manager, Manufacturing Technology.

St. Petersburg is our primary softgel development and manufacturing facility in North America with capacity of 18 billion capsules per year. Within the Catalent network, we offer a broad range of integrated formulation and analytical services to solve difficult development and manufacturing challenges.

The Senior Technical Writer tracks and maintains the area change control documentation, reviews, implements and maintains change control to quality documentation per applicable SOPs. The Senior Technical Writer has ownership, proper execution and documentation of the event, root cause analysis, impact and corrective actions.

If you would like to be part of a global drug development and delivery leader, then this role might be for you!

The Role

  • Write, review, issuance, and ensure closure of Document Change Requests (DCRs/CN), Standard Operating Procedures, and Batch Records in accordance with Catalent’s SOPs for all quality documents.

  • Serves on site project teams. Interfaces with Quality Assurance, Engineering, Product Development, Operations Management, and Validation in support of providing documentation support for new product introductions and for changes to existing products.

  • Proposes and assist in the implementation of quality improvements to document control systems.

  • Complete investigation of deviations and ensure compliant documentation; effectively compile and interpret data and identify the impact of deviations to product quality in collaboration with subject matter experts.

  • Ensures that effective corrective and preventive actions are instituted in a timely manner to prevent reoccurrence of quality events; responsible for driving closure of investigations per established timelines.

The Candidate

  • Requires an Associate's degree in a relevant business discipline, equivalent experience, or applicable combination.

  • Requires a minimum of 3 to 5 years’ experience in pharmaceutical manufacturing; a minimum of 1 to 3 years’ experience with documentation systems.

  • Direct, hands-on experience with electronic documentation systems (TrackWise, Documentation, MS Word, etc.), deviation management and deviation management systems; knowledge of TrackWise is preferred.

  • Must have experience in advanced root cause analysis tools (Fishbone, 5-Why, Brainstorming, FMEA, Process Mapping, Error-proofing, etc.). Demonstrated facilitation, problem solving, and analytical skills.

  • Capable of applying sound decision-making to problem-solve technical, compliance, or operational problems.

Position Benefits

  • Cross functional exposure to other areas of Operations

  • Medical, Dental, Vision and 401K are all offered from day one of employment

  • 19 days of paid time off annually + 7 paid holidays

We will identify candidates based on the following Catalent Competencies:

  • Leads with Integrity and Respect

  • Delivers Results

  • Demonstrates Business Acumen

  • Fosters Collaboration and Teamwork

  • Champions Change

  • Engages and Inspires

  • Coaches and Develops

About Catalent

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help develop some of the nearly 200 products we launch each year or help supply over 7,000 products for patients around the world. Catalent is an exciting and growing international company where our professionals 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, for the benefit of patients globally.

Catalent. More products. Better treatments. Reliably supplied. ™

Visit www.catalent.com/careers to explore career opportunities, or contact us at

+1 877 503 9493.

Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status. 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 along with the job number and title to Jobs@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a 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.

Catalent offers rewarding opportunities to further your career – join the global drug development and delivery leader! You will help develop some of the nearly 200 products we launch each year or help supply some of the over 7,000 products for patients around the world. Our highly skilled, dedicated global team of over 9,500 is passionate about improving the health of patients by combining their personal expertise with advanced technologies to advance science and supply innovative new products of the highest quality to patients globally.

Why Catalent?

  • Gain unparalleled experience by working on multiple products and technologies – we launch nearly 200 new products for our customers each year.

  • We have 20 global pharmaceutical Product Development teams on five continents, who are, at any given time, working on over 700 new products and hundreds of ongoing clinical trials.

  • Our products include some of the latest life-saving medicines as well as some of the most well-known consumer health brands used by families every day.

  • Catalent’s more than 30 global facilities on 5 continents manufacture over 70 billion doses of over 7,000 important medicines and consumer health products.

  • Nearly 1 in 20 doses of medicines taken around the world has been touched by the Catalent team.

  • We have +1,100 patents on many superior patient-preferred technologies used by all the top pharmaceutical, biologic and consumer health companies.

  • We established the Catalent Applied Drug Delivery Institute to drive collaboration and scientific exchange among industry professionals, academics and partners.

  • Many of our 1,400+ scientists are regularly published in top industry journals and present at top industry conferences to advance knowledge sharing and the development of better life-saving medicines.

Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status. 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 along with the job number and title to Jobs@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.