Technical Writer

PSC Biotech® Corporation; Munster; On-site; EUR 45,000 - 65,000; Full time

Job summary

PSC Biotech® Corporation is seeking a Biologics Centre of Excellence Technical Writer to manage documentation and training administration. The role ensures regulatory compliance, ALCOA/data integrity, and cross-training of personnel across sites.

The ideal candidate has a science or engineering background with proven technical writing experience and familiarity with Veeva Quality Documents and Compliance Wire. This is a 12-month contract with potential extension, based at our Ireland operations.

Qualifications

• Third level qualification in a Science or an Engineering discipline, and/or extensive related proven experience in the required areas: technical document writing

Responsibilities

• Lead the documentation management strategy and ongoing enhancements.
• Produce high-quality, accurate documentation applying data integrity and ALCOA principles.
• Serve as SME for Veeva Quality Documents & Compliance Wire.
• Draft, review, and approve BPDs, SOPs, technical protocols & reports.
• Collaborate with SMEs to gain deep product knowledge for documentation.
• Support training development and cross-site documentation activities.
• Manage transition of documentation into Veeva Quality Documents and initiate Change Requests.
• Support Global Training with BcoE training materials and modules.

Job description

About PSC Biotech

PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.

Who are we?

PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.

‘Take your Career to a new Level’

PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting.

Employee Value Proposition

Employees are the “heartbeat” of PSC Biotech, we provide unparalleled empowering career development though Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client’s expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.

Summary

• The Biologics Centre of Excellence Technical Writer supports Biologics CoE operations through effective document management and training administration. This role requires strong technical writing expertise with training coordination, thereby ensuring regulatory compliance, inspection readiness, and support personnel cross-training. The role requires demonstrated skills for initiative, self-motivation, outstanding organisational skills, and a proven ability to work independently.
• 12 Month of Contract with possibility of an extension

Key Responsibilities

• Lead, develop, and drive the ongoing enhancement of the documentation management strategy
• Produce high-quality, accurate documentation by applying data integrity and ALCOA principles, adhering to compliance best practices, and ensuring all materials are appropriate for their intended audience
• Serve as Subject Matter Expert (SME) for Veeva Quality Documents & Compliance Wire, offering guidance and support to colleagues in the use of these systems
• Draft, review, and approve BPDs, SOPs, technical protocols & reports, forms, work instructions, and other document types
• Collaborate closely with technical SMEs and teams to gain deep business and product knowledge for accurate documentation requirements
• Demonstrate excellent verbal and written communication skills to engage and motivate diverse audiences
• Propose and implement continuous improvements to the technical writing process, such as developing Advanced Templates
• Support Technical Writing activities across the site and collaborate with various departmental SMEs
• Manage the transition of documentation into Veeva Quality Documents and initiate Change Requests as necessary
• Support Global Training &/or Bus Ops with BcoE training development programs and materials, guides, and e-learning modules to address identified learning requirements

Education and Experience (required):

• Third level qualification in a Science or an Engineering discipline, and/or extensive related proven experience in the required areas: technical document writing