Specialist Technical Writing (deviation/investigation, Veeva)

Infotree Global Solutions; New Albany (OH); On-site; USD 65,000 - 90,000; Full time

Job summary

Infotree Global Solutions seeks a qualified technical writer to support the GMP manufacturing team. You will draft and revise SOPs, protocols, and training materials, ensuring documentation stays current in a regulated environment.

Responsibilities include creating and updating technical content, collaborating with multiple departments, and supporting deviations, CAPA, and change controls. Strong communication and Veeva experience are preferred.

Qualifications

• B.S. in Science or Engineering preferred.
• Experience in GMP pharma/biotech environment.
• Experience in technical writing within GMP context.
• Experience with device assembly and packaging of final product.
• Ability to translate technical content for manufacturing operators.
• Use of visuals (photos, diagrams, charts) to aid understanding.
• Experience supporting deviations, investigations, CAPA, and change controls.

Responsibilities

• Draft, revise, and maintain SOPs, protocols, technical reports, and training materials in GMP environment.
• Develop and update technical content including risk assessments and work instructions for manufacturing.
• Provide clerical support for document prep and data collection for technical records.
• Coordinate with manufacturing and cross-functional teams on documentation changes.
• Support change controls, deviations, CAPA investigations, and related records.
• Aim to reduce document turnaround times and keep schedules current.

Skills

GMP background

Excellent communication

Veeva experience

Education

B.S. in Science/Engineering

Job description

Ideal candidate: B.S. 2+ YOE would be ideal, previous Veeva experience, and prior deviation and CAPA experience.

In this role you will support the manufacturing team and provide technical expertise to regularly draft and revise documents such as Standard Operating Procedures (SOP'S), protocols, technical reports, and training material in a GMP regulated environment that supports the manufacturing process.

Develop, review, and update technical content including but not limited to standard operating procedures, work instructions, risk assessments, protocols & reports for manufacturing team.

Provide technical and clerical support to the manufacturing team in the preparation of documentation, collation of data and tracking of technical documents.

Liaise with manufacturing team and other cross functional departments regarding documentation changes in an effective and timely manner.

Collaborate with multiple departments to support new/revise training documentation for manufacturing staff.

Support process owners and participate in continuous process improvement and / or troubleshooting projects.

Support manufacturing team in reducing document turnaround times.

Ensure documentation related actions are completed on time and current schedule is maintained, accurate, and up to date.

Develop protocols for Manufacturing to support change controls, deviations & troubleshooting investigations with provision from relevant SMEs.

Generate, own, and provide subject matter expertise to Quality System records as minor deviations, CAPA and change control records.

Track pending activities required to support change control implementations.

Liaise with Quality Assurance to ensure that GMP standards are maintained in line with current operating systems.

Share knowledge with members of the manufacturing team.

Preferred Qualifications

Educational Background in Science and/or Engineering.

Experience working in GMP pharma and/or biotechnology industry.

Experience in a Good Manufacturing Practices (GMP) environment and demonstrated background in technical writing.

Experience with device assembly and packaging of final product.

Ability to translate highly technical information into easily understandable information for manufacturing operators.

Dynamic skills and usage of photographs, drawings, diagrams, animation, and charts that increase users’ understanding.

Experience supporting deviations, investigations, CAPA’s and change controls.

A fact-based problem solver with strong troubleshooting and problem-solving skills.

Pro-active with the ability to prioritize work to meet benchmarks

Good documentation and communication

Top 3 Must Have Skill Sets

• GMP background
• Excellent written and oral communication
• Preferred: B.S. 2+ YOE would be ideal, previous Veeva experience, and prior deviation and CAPA experience.