Manufacturing Operations Technical Writer

Agilent Technologies • Frederick, CO

100d • $71,680 - $112,000

About The Position

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.

Requirements

• 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.

Responsibilities

• Develop and maintain manufacturing documentation including Standard Operating Procedures (SOPs), Technical Forms, Cleaning and equipment logs, Technical reports and summaries.
• 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.
• Create and revise documents with a focus on clarity, consistency, and regulatory compliance.
• Gain deep understanding of API manufacturing processes to accurately reflect procedures and controls.
• Ensure all documentation meets current GMP, FDA, EMA, and ICH guidelines.
• Work closely with SMEs and operators to capture accurate process details.
• Identify opportunities to improve documentation practices and support lean manufacturing initiatives.
• Assist in developing training materials and documentation for onboarding and compliance.

Benefits

• Full-time equivalent pay range of $71,680.00 - $112,000.00/yr plus eligibility for bonus, stock and benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Computer and Electronic Product Manufacturing
• Education Level: Bachelor's degree