Reporting to the Site C&Q Lead, the C&Q Tech Writer is responsible for the preparation of C&Q documentation to ensure that all installation and modification to new or existing facilities, equipment, local instruments, and utilities is documented correctly and that existing equipment, instruments & utilities operate correctly and remain in a qualified state.
The C&Q Tech Writer will be expected to work closely with the other members of the Project Engineering Group, Maintenance, and members of the operational teams.
Minimum Qualifications:
Third Level Engineering / Science Qualification or equivalent experience.
Key Skills/Experience:
* Strong computer and technical writing skills.
* Knowledge of Regulus system is desirable.
* Track record in delivery of GMP facilities / C&Q projects.
Key Responsibilities:
* Defining approaches and standards to enable C&Q activities to be carried out consistently and efficiently and in conformance with applicable regulatory expectations (quality, safety and/or environmental) and established industry standards (e.g. ISPE Guidelines etc.).
* Prepare demolition, mechanical completion, IV, OV documents in accordance with templates.
* Prepare Risk Assessments, Commissioning & Qualification Plans, Verification Plans, Summary Reports and UR Documentation in accordance with templates.
* Ensure all personnel and those executing protocols are adequately trained in C&Q procedures.
* Ensure all commissioning & qualification documentation complies with all relevant local and global corporate procedures.
* Ensure that all commissioning & qualification documentation is executed in the correct order.
* Represent C&Q on project teams advising the team on C&Q requirements.
* Reviewing engineering C&Q documents and coaching other technical staff on the C&Q business process and associated practices.
* As-Building of technical data in the Engineering Data Management System.
* Oversee the transfer of C&Q documentation into the site library.
* Ensure that C&Q databases are maintained to reflect current status.
* Assist other Departments as required in miscellaneous GMP activities (re-qualification protocols, Performance Qualification, etc.).
Arcadis | DPS Group is a leading Project Management and Engineering Company delivering Full-Service Engineering with a ‘client first’ mentality and personal touch across a range of market sectors: Project and Programme Management, Procurement, Design, Construction Management, Health & Safety Management, Commissioning, Qualification and Start-up. We have one goal: to deliver more than our clients expect first time, every time.
Arcadis | DPS Group is an Equal Opportunities Employer.
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