Technical Writer - Automation Systems

Technical Writer - Automation Systems - Leiden, Netherlands - €35 - €40Per Hour - 5Months

A technical writer working within the site Data Integrity project for process automation systems. Implements changes to system documentation following the analysis of data integrity gap assessments, including security, periodic review SOP's, system design etc. Executes and reports periodic reviews of process automation and IT systems according to predefined processes. Is competent in the use of an electronic documentation management systems (EDMS). Works with the DI SME to offer guidance regarding data integrity gap remediation actions to the Business and Technical System Owners.

Principal responsibilities

Write and revise site & system SOP's etc. to include data integrity requirements

Analyse data integrity gap analysis results, propose and execute remediation actions

Guides Business and Technical System Owners in current expectation of Data Integrity

Understands both technical and procedural requirements of Data Integrity

Familiar with production systems: PLC/HMI/SCADA/MESand standalone systems such as filter integrity testers

Manages work according to a schedule Magnitudeand complexity. The focus of the function is to execute remediation actions that ensure that the Computerized Quality Systems meet the current requirements of Data Integrity. The complexity lies also in the fact that position operates in a complex, multi-functional, and sometimes multi-site environment, where continuous improvement of the Computerized Quality Systems is required.

The position requires a strong analytical and independent thinking and decision making to find structural, regulatory, and business wise sound solutions. Extensive, in depth up-to-date knowledge of manufacturing computerized quality systems and recent developments in this expertise area is a requirement.

Qualifications & Experience:

Minimum of Bachelor degree or equivalent in computer science or equivalent, supplemented with additional training or experience during work life.

Pharmaceutical or related industry work experience, of which a substantial part in Computerized Systems and related functions.

Experience in a complex, multinational work environment/company.

Project management skills and interpersonal skills, engaged in contact with personnel at all levels within the organization.

Written and oral communication skills in English and Dutch

Self-starter, planning skills, and ability to prioritize multiple commitments.

Analytical thinking and (technical) problem solving.

Pro Active, works independently, takes actions in the absence of specific instruction

Excellent communication and advisory skills, result oriented.

Additional information about the process

Johnson & Johnson is an American multinational medical devices, pharmaceutical and consumer packaged goods manufacturer founded in 1886.

This job with Johnson & Johnson is a temporary assignment and is being managed by Kelly Services on behalf of Johnson & Johnson. Successful candidates will be placed at the Johnson & Johnson assignment and managed by Kelly Services

If you match these requirements, please apply in the normal way. Elevate will send you an email, please open, click and action that email and your application will be visible to the hiring organisation directly.