JOB SPECIFICATION

The technical writer is responsible for the development, creation, revision and control of engineering documentation at our clients new biologics facility which is currently under construction. The successful candidate will establish key relationships across various project functions to ensure engineering documentation requirements are understood and delivered to support our client through project handover and into production.

Specific duties will include:

• Develop and manage document schedule to ensure engineering documentation requirements are achieved in line with overall project deliverables and key milestones.
• Work under minimal supervision to create/update controlled engineering documentation, including but not limited to, Standard Operating Procedures (SOP), Standard Work Instructions (SWI), maintenance job plans and data sheets.
• Work with the engineering function to gather, analyse and amalgamate technical information from various sources to create/update relevant engineering documentation.
• Track and report progress of document workflows and proactively escalate potential issues for resolution.
• Research existing document repository and investigate opportunities to leverage information or to update site specific procedures for use globally.
• Work collaboratively with project stakeholders and system SME’s to develop engineering documentation content and process maps.
• Act as engineering SME in GMP/nGMP documentation creation, formatting, editing, and renewal.
• Participate in cross functional team meetings (operations, engineering, quality etc.).
• Establish documentation development and maintenance practices in line with client’s global guidelines.
• Initiate and manage Change Controls within agreed timeframes using Trackwise system.
• Encourage, influence, and control the use of Good Documentation Practices (GDocP) as a crucial component of GMP compliance.
• Work with engineers and project managers to ensure that technical information contained in SOPs and SWIs is accurate and reflective of data provided for equipment qualification.

Education / Work Experience:

• Third level qualification in appropriate field (engineering, pharmaceutical, quality etc.) or relevant experience in a similar role.
• 3-5 years’ experience in technical writing, in a GMP or medical device manufacturing environment.
• Experience with engineering change controls.
• In depth knowledge of Microsoft Office (Excel, Word, PowerPoint).
• Experience with Veeva Vault, Maximo, Trackwise is an advantage.
• Excellent communication skills.

• Develop and manage document schedule to ensure engineering documentation requirements are achieved in line with overall project deliverables and key milestones.
• Work under minimal supervision to create/update controlled engineering documentation, including but not limited to, Standard Operating Procedures (SOP), Standard Work Instructions (SWI), maintenance job plans and data sheets.
• Work with the engineering function to gather, analyse and amalgamate technical information from various sources to create/update relevant engineering documentation.
• Track and report progress of document workflows and proactively escalate potential issues for resolution.
• Research existing document repository and investigate opportunities to leverage information or to update site specific procedures for use globally.
• Work collaboratively with project stakeholders and system SME’s to develop engineering documentation content and process maps.
• Act as engineering SME in GMP/nGMP documentation creation, formatting, editing, and renewal.
• Participate in cross functional team meetings (operations, engineering, quality etc.).
• Establish documentation development and maintenance practices in line with client’s global guidelines.
• Initiate and manage Change Controls within agreed timeframes using Trackwise system.
• Encourage, influence, and control the use of Good Documentation Practices (GDocP) as a crucial component of GMP compliance.
• Work with engineers and project managers to ensure that technical information contained in SOPs and SWIs is accurate and reflective of data provided for equipment qualification