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Technical Writer - Biomanufacturing SOPs & BPRs

$35 - $44 per hour
job summary:
Be part of a ground-floor startup manufacturing life-saving clinical and commercial rare disease therapies. A leading biopharmaceutical organization is seeking an experienced Technical Writer to author critical operational documentation for a new purification facility.

location: Durham North Carolina
job type: Contract 
salary: $35-$44 per hour
work hours: 9:00 AM – 5:00 PM
education: Bachelors Degree

 

responsibilities:

  • Author technical Standard Operating Procedures (SOPs) and Batch Production Records (BPRs) from scratch to support facility startup.
  • Walk down manufacturing processes and collaborate cross-functionally with Manufacturing Operators, QA, Engineering, and Maintenance.
  • Develop documentation for cleanroom gowning, cleaning, raw material dispensing, equipment operation, and single-use processing assemblies.
  • Drive technical review workflows and incorporate feedback to secure timely stakeholder approvals against production schedules.
  • Integrate human safety and cGMP compliance principles into all operational manufacturing documentation.
qualifications:

  • B.S. degree in an Engineering or Scientific discipline.
  • 3+ years of technical documentation authoring experience in a biopharma manufacturing setting.
  • Working knowledge of cGMP standards and bioprocess equipment.
  • Demonstrated ability to synthesize complex SME input into clear, concise operational instructions.
  • Strong independent project delivery skills in fast-paced production environments.
#LI-AM1

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact View email address on us.fitly.work.




Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).




This posting is open for thirty (30) days.



Vacancy posted 6 days ago
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