Technical Writer

Technical Writer Role 

Location: Johnson & Johnson In Limerick 

Hybrid working  - Ideally working 2/3days on site and the remaining remote. 

ASAP start - 12 Month Contract

Hours:  40 per week

Hourly Pay Rates: €26 - €29 PH  / €35 - €38 Ltd

The Company:

Johnson & Johnson is the world's most comprehensive and broadly-based healthcare Company, touching the lives of nearly a billion people every day. Our Family of Companies throughout the world compete in consumer, pharmaceutical and medical devices & diagnostics markets and have the skills and resources to tackle the world's most pressing health issues.

The Role:

To provide support for the technical/validation documentation and support activities within NPI Team to ensure that all activities associated with change control and general documentation support tasks are completed in a fully compliant manner in accordance with the requirements of Johnson & Johnson Validation/Quality Policies and Procedures. The role requires collaboration with Quality Engineering to ensure Johnson & Johnson Validation/Quality Policies and Procedures are maintained.

Responsibilities:

Main areas of responsibility:

• Perform technical writing activities and assist the project engineers in the generation of validation documentations including URS’s, FAT’s, SAT’s, test plans, deviations and discrepancies. 
• Update and edit Operations Procedures, Work Instructions, project manuals, project presentations and reports.
• To provide assistance with Change Control process to ensure that change implementation activities and deliverables are coordinated effectively in order to meet both the TRB and CCB requirements and timelines.
• Help coordinate FMEA sessions with Validation and Engineering as needed.
• Assist with attachment and upload of deliverables associated with change control.
• Help with non-critical Validation execution under direction of Validation Engineer.
• Assist with purchasing and spare parts ordering
• Ensure accuracy and consistency of the technical/validation documentation. 
• Ensure all quality/validation documents are authorized and appropriate compliance approval is gained.
• Update procedures as required.

Skill sets Required

• Expertise in the use of Microsoft Word, Excel and PowerPoint and electronic document management systems.
• Excellent verbal and written communication skills 
• Excellent customer service, interpersonal and team collaboration skills are essential  
• Works independently and/or within a team to accomplish job objectives. 
• Self-Starter 
• Establishes and follows priorities 
• Suggest and sometimes may implement innovation and continuous improvement within the technical/validation writing process or within the Engineering process.
• Builds cross functional and cross-departmental support, fostering overall effectiveness 

Essential Education & Experience Requirements:

• Qualification in an appropriate discipline (e.g. Engineering, Information Systems, or Life Science with additional IT qualification) with a broad technical/educational skills base 
• Understanding of GMP, Compliance, Validation Practices including the system development life cycle and Regulatory expectations.

Desirable:    

• Knowledge of 21 CFR 820, 21 CFR 11 and European regulations associated with the medical device industry.
• Experience working in a regulated environment would be an advantage