Manufacturing Operations Technical Writer

Job Description

At Agilent, we are driving innovation in life-changing, lifesaving medicines. Join our team in advancing the next frontier of biopharma by supporting the production of nucleic acid therapeutics. We offer an opportunity to be part of a high-performance manufacturing team dedicated to delivering perfection in our new innovative facility. Together, we’re helping craft the future of medicine.

Key Responsibilities

• Develop and maintain manufacturing documentation including:
• Collaborate with cross-functional teams (Manufacturing, QA, QC, Engineering, Regulatory) to gather technical information and ensure accuracy.
• Translate complex manufacturing processes into clear, concise, and compliant documentation.
• Support change control activities by updating documentation in response to process improvements or regulatory requirements.
• Participate in document reviews, audits, and inspections.
• Ensure timely completion and approval of documentation to support production schedules.
• Maintain document version control and archival in accordance with GMP and company policies.
• Standard Operating Procedures (SOPs)
• Technical Forms
• Cleaning and equipment logs
• Technical reports and summaries

Essential Functions

• Technical Writing: Create and revise documents with a focus on clarity, consistency, and regulatory compliance.
• Process Understanding: Gain deep understanding of API manufacturing processes to accurately reflect procedures and controls.
• Compliance: Ensure all documentation meets current GMP, FDA, EMA, and ICH guidelines.
• Collaboration: Work closely with SMEs and operators to capture accurate process details.
• Continuous Improvement: Identify opportunities to improve documentation practices and support lean manufacturing initiatives.
• Training Support: Assist in developing training materials and documentation for onboarding and compliance.

Qualifications

• Bachelor's degree in a science-related field or equivalent experience.
• 2+ years of meaningful experience, ideally in a GMP manufacturing environment.
• Strong understanding of GMP guidelines and international regulations for API and drug production.
• Experience with technical writing and SOP development.
• Experience with root cause analysis and CAPA development preferred.
• Proficient in Microsoft Word and other standard software applications.
• Excellent communication and leadership skills, with the ability to run cross-functional teams and sophisticated projects.

Additional Details

This job has a full time weekly schedule. Applications for this job will be accepted until at least September 23, 2025 or until the job is no longer posted.The full-time equivalent pay range for this position is $71,680.00 - $112,000.00/yr plus eligibility for bonus, stock and benefits. Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at: https://careers.agilent.com/locationsAgilent Technologies, Inc. is an Equal Employment Opportunity and merit-based employer that values individuals of all backgrounds at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, national origin, ancestry, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other basis protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases. Agilent Technologies, Inc., is committed to creating and maintaining an inclusive in the workplace where everyone is welcome, and strives to support candidates with disabilities. If you have a disability and need assistance with any part of the application or interview process or have questions about workplace accessibility, please email job_posting@agilent.com or contact +1-262-754-5030. For more information about equal employment opportunity protections, please visit www.agilent.com/en/accessibility.

Travel Required:

No

Shift:

Day

Duration:

No End Date

Job Function:

Quality/Regulatory