Tech Writer

Desired Skills: MS Office Suite,Science,Engineering,Chemistry,Microbiology,Validation,Project management,change controls

The Role

PE Global are recruiting for a Technical Writer for our biopharmaceutical client based in Dun Laoghaire, Dublin. This is a 12 -month contract role. Hybrid working options.

Job Responsibilities

• Develop, review and update engineering, manufacturing, & inspection Standard Operating Procedures.
• Liaise with Manufacturing/Inspection/Engineering regarding documentation changes in an effective and timely manner.
• Develop protocols for execution in Manufacturing & Inspection in support of change controls, deviations & troubleshooting investigations with support from relevant SMEs.
• Involvement in projects as part of continuous process improvement and / or troubleshooting,
• Ownership and management of change controls as required
• Issuance and updates of paper batch records in line with production schedule
• Liaise with Quality Assurance to ensure that GMP standards are maintained in line with current OS
• Partner with Operations lead/appropriate SME to ensure updates are correct and aligned with project deliverables/ timelines.
• Perform document trending upon project completion to identify keys issues/mistakes in document processing.
• Support data verification of Operations owned protocols reports and risk assessments
• Support the production support team in reducing document turnaround times
• Use specified software packages and standard procedures, responsible for compiling and maintaining all relevant documentation including SOPs
• Provide technical and clerical support to the manufacturing, inspection & engineering teams in the preparation of documentation, collation of data and tracking of SOPs
• Ensure Non-conformance are triage within the established goal and serve as a deviation owner for minor deviations.
• Own corrective /preventative actions and effectiveness verification.

Education and Experience

• Bachelor’s degree in a Science or Engineering discipline.
• 3+ years of experience in Chemistry/Microbiology/Engineering/Validation gained within a biotech, pharma or health care organization
• Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products an advantage
• Strong Project Management and organizational skills, including ability to follow assignments through to completion
• Excellent verbal and written communication skills: Strong Technical writing skills for GMP documentation (e.g., investigations, procedures, change controls) and good Presentation skills
• Escalate issues professionally and in a timely manner
• Ensures compliance within regulatory environment
• Demonstrated ability to work independently and deliver right first-time results under minimal direction
• Experience participating in and leading cross-functional teams
• Experience in managing multiple, competing priorities in a fast-paced environment

Interested candidates should submit an updated CV.

Please click the link below to apply, or alternatively send an up-to-date CV aisling.oleary@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland****