Technical Writer

The Technical Writer will Develop, create and maintain documentation, particularly protocols and Master Batch Records in accordance with company policy.

Catalent Cell & Gene Therapy hires people with a passion to make a difference. Your expertise, coupled with our advanced technologies and collaboration with innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives.

The role:

• Develop, create and maintain documentation, particularly protocols and Master Batch Records in accordance with company policy; maintain hardcopy and electronic files in a software database as required
• Coordinate document approval across the organization; provide lean and agile response to changing priorities in service of multiple business units for both packaging and manufacturing activities
• Interface with validated and regulated computer software to ensure documents, work orders, and data are flowing according to procedure and that inputs are accurate for on-time batch execution
• Work with Subject Matter Expert (SME) to gather the information needed to create new 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 and assist in making inputs to the Manufacturing Resource Planning in preparation for manufacturing events

The candidate:

• Bachelor's degree; previous technical writing experience preferred
• High school diploma or equivalent with at least 2 years of relevant industry experience; previous technical report writing preferred
• Ability to administer quality system programs and resources
• Familiar with GMP documentation requirements
• Proficient with Microsoft Office Word and Excel and Adobe Professional
• Experience with database management software

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 [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.