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Technical Writer Biomanufacturing

Employer
Catalent Pharma Solutions Inc
Location
Madison
Salary
Competitive

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Position Overview:

Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent's advanced technologies and collaboration with thousands of 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. Interested in learning more about life at Catalent? Start here

Technical Writer - Biomanufacturing

Position Summary:

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.

Catalent Pharma Solutions is currently seeking a Technical Writer - Biomanufacturing who under minimal supervision, will author and revise deviations, preventative actions, change controls and other related cGMP documents across manufacturing campaigns. The Technical Writer - Biomanufacturing will work in collaboration with Quality, Manufacturing Sciences and (MS&T) and Manufacturing Subject Matter Expert's to support deviation investigations, root cause analysis and effective corrective preventative actions (CAPA). The role supports multifaceted upstream, downstream Technologies and solution preparation processes to resolve obstacles related to drug substance manufacturing. Compliance with established GMP, safety, and regulatory regulations is required.

This is a full-time, salaried position: Monday - Friday, 8:00am - 5:00pm

Catalent Biologics in Madison is based in our new, state of the art, 100,000 square foot facility, with expanded mammalian cell line engineering and biomanufacturing capabilities utilizing single-use systems. Catalent-Madison employees are helping to improve future patient outcomes by working on products that are designed to treat cancer, various autoimmune, fibrotic and blood disorders, HIV, diabetes, heart and lung diseases as well as Alzheimer's and more.

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
  • Under minimal supervision, authors and revises deviation records, preventative actions and other related cGMP documents in a timely manner.
  • Becomes familiar with upstream, downstream, materials management, production facility, systems, and technologies to facilitate the accurate completion of responsibilities.
  • Track/monitor and provide timely, accurate information regarding status of open investigations.
  • Actively engage in Inspection Readiness activities and teams.
  • Provide guidance to write and revise SOPs (Standard Operating Procedures) when gaps are identified.
  • May provide support to internal and client audits as needed.
  • Responsible for exhibiting professional behavior with internal and external associates that reflects positively on the company and is consistent with the company's policies and practices
  • Other duties as assigned
The Candidate
  • B.S./B.A. in Biotechnology with minimum of 1 year' industry experience; or M.S in Biotechnology, or related field.
  • Associates Degree/Certificate/Diploma with a minimum of 2 years' experience in related GMP environment.
  • High School Diploma or equivalent with a minimum of 3 years' experience in related GMP environment.
  • Minimum of 1-2 years of relevant experience in cGMP manufacturing, documentation, biology, quality assurance, or equivalent
  • Possess knowledge, understanding, and application of cGMP's as it relates to both Clinical and Commercial operations
  • Detail oriented and proficient in Microsoft Office applications
  • Strong listening and interpretive skills to successfully translate events into clearly written documents
  • Ability to work independently, within prescribed guidelines, or as a team member to meet timelines for completion and approval of investigations
Why you should join Catalent:
  • Defined career path and annual performance review and feedback process
  • Diverse, inclusive culture
  • 19 days of PTO + 8 paid holidays
  • 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 quarterly 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
  • On-site fitness center and wellness programs
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.
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C atalent 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, protected veteran status, sexual orientation or gender identity. 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.

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 for us to investigate with local authorities.

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