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Technical Writer I - Manufacturing Sciences & Technology

Postion 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 Biologics is a fast-growing business within Catalent Pharma Solutions focused on providing innovative technologies and solutions to help more and better biologic treatments get to patients. Working for Catalent Biologics is an opportunity to join an entrepreneurial team. Catalent Biologics is making significant investments in people and capabilities. This is a unique opening to join a small, fast-growing business, backed by a global public company. People joining our team will have the opportunity for career development as our business continues to grow and expand. Catalent-Madison employees are helping to improve future patient outcomes by working on products that are designed to treat COVID-19, cancer, various autoimmune, fibrotic and blood disorders, HIV, diabetes, heart, and lung diseases as well as Alzheimer’s.

The Technical Writing group is responsible for document generation at Catalent, Madison. The group has key functions that include Master Batch Production Record (BPR), protocol, and summary report generation. BPRs are drafted for use in Process Development and Manufacturing. The documents are prepared by trained authors and support Good Documentation Practices and consistent instructions to operators. Protocols are prepared by the team to support studies for Process Development, including Process Characterization and Reference Standard Characterization. Reports are prepared to capture development and/or batch performance of all Cell Line Development, Process Development, Analytical Development, and Manufacturing.

This Technical Writer I, Manufacturing Sciences & Technology will coordinate and write the cGMP manufacturing batch records or batch summary reports for platform processes. The position responsibilities will include addressing revisions to the documents, supported by subject matter experts. The position is expected to possess a scientific or writing background, strong organizational skills, and a high attention to detail.

This is a full-time hybrid position with requirements to be on site as needed, Monday - Friday 8:00am to 5:00pm CST.

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:

• Authors process batch production records to support cGMP manufacturing with minimal technical understanding.

• Generates batch production records in accordance with applicable regulator guidance and site SOPs.

• Works closely with subject matter experts (SMEs) from multiple departments for batch record-related tasks.

• Responds to internal comments and works with SMEs to ensure comments are incorporated.

• Executes procedures of moderate complexity with high quality with a minimum degree of guidance.

• Other duties as assigned.

The Candidate:

• Associate’s degree in a STEM discipline and 4+ years related experience required OR Bachelor's degree in a STEM discipline and 1+ years related experience required.

• Has applied knowledge of Word, Excel, PowerPoint, and can apply technical knowledge to assist and train the site with Microsoft troubleshooting.

• Able to understand and write assigned SOPs and moderately complex batch production records with minimal guidance; can execute work plan/schedule developed with input from senior team member.

• Ability to manage time effectively to complete assignments in expected time frame and independently seek out additional work when tasks are completed ahead of time

• Excellent written communications skills with internal customers; ability to cooperate with coworkers within an organized team environment or work alone; detail oriented with ability to work effectively under high pressure with multiple deadlines.

• Work environment: Working in a lab environment will require working with skin irritants, lung irritants, electrical equipment, sharp instruments, toxic materials, and hazardous waste. Safety procedures will be followed to minimize exposure, including clean room gowning. Frequent sitting, standing, walking, reading of written documents and use of computer monitor screen, reaching with hands and arms, talking, writing, listening. Occasional stooping, kneeling, crouching, bending, carrying, grasping. Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 50 pounds.

Why you should join Catalent:

• Defined career path and annual performance review and feedback process

• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives

• Dynamic, fast-paced work environment

• Generous 401K match and Paid Time Off accrual

• Medical, dental and vision benefits effective day one of employment

• Tuition Reimbursement

• Wellhub program to promote overall physical wellness

• Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories

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.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers (https://careers.catalent.com/us/en) 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 DisabilityAccommodations@catalent.com . 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 spam@catalent.com for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .