Technical Writer

PSC Biotech® Corporation; Munster; On-site; EUR 50,000 - 65,000; Full time

Job summary

PSC Biotech is seeking a Biotech documentation professional to lead the ongoing enhancement of our documentation management strategy. The role requires strong technical writing and the ability to coordinate training activities for regulatory compliance.

You will draft, review, and approve BPDs, SOPs, and other critical documents while serving as SME for Veeva Quality Documents and Compliance Wire. Collaboration with technical SMEs will be essential to ensure accurate, compliant documentation

Qualifications

• Technical writing experience with training coordination.
• Strong organisational skills and ability to work independently.
• Experience drafting and managing GMP/quality documentation such as SOPs, BPDs and reports.

Responsibilities

• Lead, develop, and drive the ongoing enhancement of the documentation management strategy.
• Draft, review, and approve BPDs, SOPs, technical protocols & reports, forms, work instructions, and other document types.
• Serve as Subject Matter Expert (SME) for Veeva Quality Documents & Compliance Wire, offering guidance and support.
• Collaborate with technical SMEs to gain deep product knowledge for accurate documentation requirements.
• Support Global Training/Bus Ops with BcoE training development programs and materials.

Skills

Technical writing

Training coordination

Regulatory compliance

Cross-functional collaboration

Education

Science or Engineering degree

Tools

Veeva Quality Documents

Compliance Wire

Job description

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