Manufacturing Operations Technical Writer

Agilent Technologies
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.

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What This Job Offers

Job Type

Full-time

Career Level

Entry Level

Education Level

Bachelor's degree

Number of Employees

5,001-10,000 employees

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