Technical Writer

Role: Technical Writer

Location: Castletroy, Limerick

Work type: Full time on site

Start date: As soon as possible

Contract duration: 12 months 

Hours: 40 hours a week

Hourly pay rate: Depending on experience

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 engineering to ensure that all activities associated with change control and general Engineering 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.

Duties and Responsibilities:

• Perform technical writing, research, and related editing functions to prepare documents, test plans, user cases, project manuals, business proposals, reports, briefings, presentations, guidelines, and other written materials. 

• 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 Engineering as needed.

• Assist with attachment and upload of deliverables associated with change control.

• Help with non-critical Validation execution under direction of Engineering.

• Assist with purchasing and spare parts ordering

• Support Engineering with planning and department development.

• Provide training on quality systems.

• Manages and monitors the change control metrics.

• Ensure accuracy and consistency of the technical/validation documentation. 

• Ensure all quality/validation documents are authorized and appropriate compliance approval is gained.

• Update procedures

Desireble Experiance

• Experience working in a regulated environment would be an advantage

• Understanding of GMP, Compliance, Validation Practices including the system development life cycle and Regulatory expectations.

• Knowledge of 21CFR 820, 21 CFR 11 and European regulations associated with the medical device industry.

• Expertise in the use of Microsoft Word, Excel and Power Point and electronic document management systems.

• Excellent verbal and written communication skills 

Education 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

Other Requirements:

• Excellent customer service, interpersonal and team collaboration skills are essential  

• Establishes and manages engagement objectives and expectations, Works independently and/or within 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.

In Return:

In return for this role you will receive a very competitive hourly rate. A minimum 12 month contract & an opportunity to work with a Global Leader within the Pharmaceutical sector, Johnson & Johnson. 

Diversity, Equity & Inclusion:

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences

That is why we in Ireland are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.

Thank you very much and we look forward to receiving your application.