Biologics Technical Writer & Training Lead

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

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.