Manufacturing Technical Writer - Bio/Pharma

Randstad Enterprise is looking for a motivated, experienced Technical Writer to jump in and support the Manufacturing Technical Operations with creation of manufacturing process instructions to support day-to-day tasks/operations. This is an opportunity to expand experiences and learn while working in a well-respected Biomanufacturing company. Previous experience in authoring of manufacturing technical instructions and batch records requires high factual/procedure accuracy and an in depth understanding of scientific concepts to translate information effectively.

• 100% onsite in RTP
• Contract: 6 months (very small potential for extension or a full-time conversion)
• Benefits available through Randstad

Necessary Skills & Experience:

• 2 years of experience creating or updating documentation in Bio/Pharma Manufacturing
• Knowledge of cGMP principles
• Demonstrable ability to write with strong oral and written communication
• Ability to hit the ground running and work independently
• Possesses technical knowledge of Manufacturing equipment and processes – demonstrating minor level of technical depth and process knowledge of Manufacturing operations
• Strong technical writing skills and ability to synthesize information from multiple SMEs into a coherent, clear and concise narrative
• Ability to interpret technical information and documentation used for operations and production activities.
• Knowledge of UF/DF, Buffer Preparation, Raw Materials Dispensing, or Chromatography
• Experience with single-use manufacturing
• Previous experience in a new plant startup
• Previous experience as a manufacturing operator, supervisor, or engineer
• Knowledge of Commissioning, Qualification, and Validation (CQV)

Main focus of the Job:

• Write technical Standard Operating Procedures (SOPs) and Batch Production Records (BPRs) to support a new purification facility startup for the manufacture of clinical and commercial rare disease drugs.
• Documentation scope includes SOPs for operating equipment, gowning into a clean manufacturing area, cleaning of rooms and equipment, dispensing raw materials, and working with single-use processing assemblies.
• Work independently and cross-functionally with Manufacturing Operators, Quality Assurance, Engineering, and Maintenance to define the scope of documentation, walk down the process in the manufacturing facility, draft new SOPs, and work with stakeholders for feedback and approvals. Own the creation of multiple documents from scratch and deliver according to manufacturing timelines.
• Incorporate safety principles into documentation and any work performed in manufacturing area.

Education:

· B.S. Degree in Engineering or Scientific Discipline